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Child health Gastrointestinal

Colic - infantile

Last revised in December 2022

Infantile colic is a self-limiting condition which is defined clinically as repeated episodes of excessive and inconsolable crying in an infant

Colic - infantile: Summary

  • Infant colic is defined by the following clinical diagnostic criteria:
    • The infant is less than 5 months of age when the symptoms start and stop.
    • There are recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers.
    • There is no evidence of faltering growth, fever, or illness.
  • Additional clinical signs of infantile colic may include:
    • Crying which most often occurs in the late afternoon or evening.
    • Drawing the knees up to the abdomen or arching the back when crying.
    • Clenching of the fists.
  • It is a self-limiting condition and the underlying cause is not fully known.
    • It may reflect a neurodevelopmental stage causing an exacerbation of normal infant crying due to abnormal gastrointestinal motility and gas production; reduced gut microbiome diversity; central nervous system deregulation; and psychosocial factors.
  • Epidemiological studies suggest the prevalence of infantile colic is higher in the first six weeks of life, and it occurs equally in breastfed and bottle-fed infants.
  • Complications include parent or carer stress and sleep deprivation, fatigue, loss of confidence in parenting skills, anxiety or depression, premature cessation of breastfeeding, and increased risk of child maltreatment.
  • Assessment of an infant with suspected colic should include:
    • Asking about the onset, duration, frequency, and timing of crying episodes; exacerbating and relieving factors; red flags suggesting possible serious illness; antenatal and birth history; birth weight and gain or loss; any associated symptoms suggesting an underlying cause; feeding and sleeping patterns; and winding techniques.
    • Asking about parent/carer coping strategies; impact on the family; risk of complications; support available; parental atopy, smoking, or alcohol; and any issues with breastfeeding.
    • Examination for red flag signs suggesting possible serious illness; serial weight measurements; orofacial conditions that may affect feeding; muscle tone and neurological signs suggesting an underlying cause; and parent/carer interaction with the infant.
  • Management of an infant with suspected colic should include:
    • Advising about sources of information and support.
    • Providing reassurance about crying in otherwise well infants, and strategies that may help such as holding the baby, gentle motion, white noise, and using optimal winding techniques.
    • Encouraging parents/carers to look after their own wellbeing by resting when able, accessing support, and taking 'time out' if needed.
    • Encouraging to continue breastfeeding wherever possible.
    • Advising on strategies that are not recommended.
    • Arranging follow-up depending on clinical judgement.
  • Specialist paediatric referral or advice should be sought if:
    • Parents/carers feel unable to cope despite reassurance and advice in primary care.
    • There is suspected faltering growth, or symptoms are severe, worsening, or persist beyond 5 months of age.
    • There is a suspected underlying cause for symptoms which cannot be managed in primary care.

Have I got the right topic?

From birth to 6 months.

This CKS topic covers the management of infantile colic with no obvious underlying cause.

This CKS topic does not cover the management of other forms of colic, or colic associated with conditions such as constipation, cow's milk allergy, food allergy, or gastro-oesophageal reflux disease.

There are separate CKS topics on Breastfeeding problems, Constipation in children, Cow's milk allergy in children, Faltering growth, Food allergy, and GORD in children.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.

How up-to-date is this topic?

Changes

December 2022 — reviewed. A literature search was conducted in November 2022 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. The recommendations have been amended in line with current evidence. The diagnostic criteria for infantile colic have been updated in line with the Rome IV criteria for functional gastrointestinal disorders in infants and toddlers (2016).

Previous changes

March 2022 — minor update. A link to a patient information leaflet has been removed from this topic.

June 2017 — reviewed. A literature search was conducted in May 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. The recommendations on assessment have been expanded, and the management options in primary care have been amended in line with current evidence.

November 2014 — minor update. The scope of the topic has been changed to include the management of children with no obvious underlying cause of colic. Links have been provided to the CKS topics on cows' milk protein allergy, gastro-oesophageal reflux in children, and constipation in children, for recommendations on the management of children where these conditions are suspected or confirmed.

August 2012 — reviewed. A literature search was conducted in July 2012 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of the topic. No major changes to clinical recommendations have been made.

June 2011 — technical update. The management section of this topic has been simplified to improve clarity and navigation. There have been no changes to the clinical content or meaning of the recommendations with two minor exceptions: information about the history and examination was added to the section on Diagnosis, and the choice of hypoallergenic infant formulas has been revised. 

March 2011 — minor update. Minor text correction. 

November 2010 — minor update. Pregestimil® and Nutramigen 1® have been re-branded as Pregestimil LIPIL® and Nutramigen 1 LIPIL®. Issued in November 2010.

October 2009 — minor update. Description of use of lactase as an off-label indication for unproven lactose intolerance has been removed. Lactase drops are not a medicinal product and therefore have no licensed indications. 

May to September 2007 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. There are no major changes to the recommendations.

November 2005 — minor technical update. 

June 2004 — reviewed. Validated in September 2004 and issued in November 2004.

June 2001 — reviewed. Validated in November 2001 and issued in April 2002.

September 1998 — written.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 November 2022.

HTAs (Health Technology Assessments)

No new HTAs since 1 November 2022.

Economic appraisals

No new economic appraisals relevant to England since 1 November 2022.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since November 2022.

Primary evidence

No relevant randomized controlled trials published since 1 November 2022.

New policies

No new national policies or guidelines since 1 November 2022.

New safety alerts

No new safety alerts since 1 November 2022.

Changes in product availability

No changes in product availability since 1 November 2022.

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Identify when a diagnosis of infantile colic is suspected.
  • Exclude other underlying causes of infantile colic symptoms.
  • Advise on management strategies in primary care.
  • Arrange referral to a health visitor, nursery nurse, or paediatrician if clinically appropriate.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

No audit criteria were found during the review of this topic.

QOF indicators

No QOF indicators were found during the review of this topic.

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE quality standards

No NICE quality standards were found during the review of this topic.

Background information

What is it?

  • The Rome IV criteria for functional gastrointestinal disorders in infants and toddlers defines infantile colic according to the following clinical diagnostic criteria [Zeevenhooven, 2017]:
    • The infant is less than 5 months of age when the symptoms start and stop.
    • There are recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers.
      • 'Fussing' refers to intermittent distressed vocalization that is not quite crying, but 'not awake or content either'. An infant may fluctuate between fussing and crying, and the two symptoms can be difficult to distinguish in clinical practice.
    • There is no evidence of infant failure to thrive, fever, or illness. See the CKS topic on Faltering growth for more information.
  • The modified 'Wessel's criteria' are no longer recommended in the Rome IV criteria as the timescale of three hours was seen as too arbitrary, the criteria being too culturally-dependent, and the need to fill out behaviour diaries for 7 days was felt to be too intensive and time-consuming for caregivers [Zeevenhooven, 2017]. 
    • The modified 'Wessel's criteria' used in research studies were defined as episodes of irritability, fussing, or crying that begin and end for no apparent reason and last at least three hours a day, at least three days a week, for at least one week, in an infant up to 4 months of age with no evidence of faltering growth [Hyman, 2006].
  • Additional clinical signs of infantile colic may include [Vandenplas, 2015a] [Mai, 2018] [Zeevenhooven, 2018]:
    • Crying which most often occurs in the late afternoon or evening.
    • Drawing the knees up to the abdomen or arching the back when crying.
    • Clenching of the fists.

What causes it?

The underlying cause of infantile colic is not known, and it may reflect a neurodevelopmental stage causing an exacerbation of normal infant crying due to physiological and psychosocial factors [Akhnikh, 2014] [Zeevenhooven, 2017] [Mai, 2018] [Sung, 2018].

  • Abnormal gastrointestinal motility and pain signals from sensitized pathways in the gut viscera; excess gas production in the gastrointestinal tract; and possible gut inflammation may be mediated by the microbiome-gut-brain axis [Mai, 2018; Zeevenhooven, 2018].
    • Reduced gut biome diversity, including reduced Lactobacilli and increased coliform bacteria in the intestinal microflora, may influence gut motor function and result in increased gas production due to colonic bacterial fermentation.
  • Central nervous system deregulation and possible differences in sensory processing may result in easily triggered crying which is difficult to soothe [Zeevenhooven, 2017].
  • Psychosocial factors such as family tension; parental anxiety or depression; inadequate parent-infant interaction; overstimulation of the infant; or misinterpretation of crying [Zeevenhooven, 2017; Mai, 2018].

How common is it?

The prevalence of infantile colic varies in the literature, depending on the study type and population, the definition of colic, and parental perception of the intensity and duration of crying episodes. It is likely to be under-reported to healthcare professionals [Lucassen, 2001] [Zeevenhooven, 2017].

  • A systematic review of 30 studies reported a worldwide prevalence of infantile colic ranging from 2–73%, with an average prevalence of about 20% in infants under 12 months of age [Vandenplas, 2015b].
  • A systematic review of 15 community-based retrospective and prospective surveys of the prevalence of infantile colic found [Lucassen, 2001]:
    • The cumulative incidence rate in prospective studies ranged from 3–28%.
    • The period prevalence rate in retrospective studies ranged from 8–40%.
    • The reported prevalence rates varied depending on the methodological quality of the studies.
  • A meta-analysis of 28 diary studies (n = 8690 infants) found the prevalence of colic was higher in the first 6 weeks of life (17–25%) compared with 11% by 8–9 weeks of age, and 0.6% by 10–12 weeks of age [Wolke, 2017].
  • Expert opinion in a review article states that one in six families with children with colic symptoms consult a healthcare professional [DTB, 2013].
  • Colic occurs equally in breastfed and bottle-fed infants, and in both sexes [Johnson, 2015; Vandenplas, 2015a].

What are the complications?

Possible complications of infantile colic include [DTB, 2013] [Mai, 2018] [Sung, 2018] [Zeevenhooven, 2018] [Ellwood, 2020]:

What is the prognosis?

  • Infantile colic is a self-limiting condition that usually improves by 3–4 months of age, and should resolve by 5–6 months of age [Mai, 2018; Sung, 2018; Johnson, 2015; Zeevenhooven, 2018].
  • There is conflicting evidence from small studies on whether infants with colic are at increased risk of developing psychological, behavioural, or other conditions (such as allergic or functional gastrointestinal disorders) in later life [Akhnikh, 2014; Vandenplas, 2015b; Mai, 2018].

Diagnosis of infantile colic

How should I assess an infant with suspected colic?

If infantile colic is suspected, the diagnosis should only be made following exclusion of other possible causes of symptoms, and assessment should include history and examination of both the infant and parents/carers.

  • Ask about:
    • Infant history:
      • The onset, duration, frequency, and timing of crying episodes; change in tone or pitch of crying; and any alleviating or exacerbating factors.
        • A weak, abnormally high-pitched, or continuous cry is a red flag which may indicate potentially serious illness.
        • Other red flags include fever, apnoeic episodes, cyanosis, abnormal breathing pattern, bilious or projectile vomiting, weight loss or faltering growth, and blood in the stool.
      • Birth gestation, any birth trauma or known medical conditions or congenital abnormalities (such as ankyloglossia [tongue-tie] or cleft lip and/or palate) that may affect breastfeeding. See the CKS topic on Breastfeeding problems for more information.
      • Birth weight, weight gain or faltering growth, general health, and behaviour. See the CKS topic on Faltering growth for more information.
      • Associated symptoms such as reflux, constipation, or rash that may suggest another underlying cause. See the CKS topics on GORD in children, Constipation in children, Cow's milk allergy in children, and Food allergy for more information.
      • Feeding pattern (frequency, duration, night feeds) and any feeding problems; timing between crying and feeds; method of reconstituting formula feeds (if used); winding technique; and what other fluids or foods have been given (including when they were introduced, quantity, and frequency). See the CKS topic on Breastfeeding problems for more information.
      • Use of a dummy or pacifier and infant sleeping pattern/routine.
    • Parental/carer history:
      • Parental responses to crying, including coping strategies, and impact on the parents and family, including any siblings.
      • Associated insomnia, stress, anxiety, depression, or postnatal depression. See the CKS topics on Insomnia, Generalized anxiety disorder, Depression, and Depression - antenatal and postnatal for more information.
      • Beliefs, ideas, concerns, and expectations about infant crying, feeding, and sleep.
      • Family or other support available, including health visitor, nursery nurse, and/or social worker input.
      • Any complications during pregnancy, labour, or post-partum.
      • History of atopy or allergies and alcohol and smoking history.
      • Maternal breast and/or nipple pain and use of nipple shields or breast shells that may affect breastfeeding. See the CKS topics on Breastfeeding problems and Mastitis and breast abscess for more information.
      • Maternal diet if breastfeeding, for example, excessive coffee, tea, or soft drinks that contain caffeine, or excessive alcohol or spicy food.
  • Examine the:
    • Infant for:
      • Suitability of clothing to maintain appropriate body temperature.
      • Signs of fever, dehydration, or raised intracranial pressure.
      • Weight and serial measurements of weight gain or loss. See the CKS topic on Faltering growth for more information.
      • Skin rash or signs of itch that may cause discomfort.
      • Oral anatomy (ankyloglossia, palate, jaw, and lips), oral Candida infection, or nasal congestion that may affect sucking and swallowing. See the CKS topics on Breastfeeding problems and Candida - oral for more information.
      • Muscle tone, any neurological deficits, and behaviour.
      • Signs of bruises, petechiae, or trauma that may suggest child maltreatment. See the CKS topic on Child maltreatment - recognition and management for more information.
    • Woman's:
      • Nipples and breasts if there are concerns about breastfeeding problems. See the CKS topic on Breastfeeding problems for more information.
    • Parent's/carer's:
      • Interaction with the infant and handling.
  • Ensure that a person with appropriate training and expertise (such as a health visitor or breastfeeding specialist) observes the woman breastfeeding and expressing milk if there are concerns about breastfeeding problems.

Basis for recommendation

The recommendations on assessment are based on expert opinion in the National Institute for Health and Care Excellence (NICE) clinical guideline Postnatal care [NICE, 2022] and expert opinion in review articles on infantile colic [DTB, 2013; Johnson, 2015; Sung, 2018; Zeevenhooven, 2018], unexplained crying in infants [McKenzie, 2013; Allister, 2014], and infant gastrointestinal symptoms [Vandenplas, 2015a]. They are also pragmatic, based on what CKS considers to be good clinical practice.

  • Expert opinion in a review article notes the importance of exclusion of underlying organic causes, which occur in less than 10% of infants presenting with crying, that typically present with additional clinical features [Sung, 2018].
  • The information that a weak, abnormally high-pitched, or continuous cry is a red flag, and the other clinical features that may indicate potentially serious illness, are based on the NICE guideline and expert opinion in a review article [Zeevenhooven, 2018].
  • Expert opinion in a review article on troublesome crying in infants notes that crying is the commonest trigger for physical maltreatment of an infant [McKenzie, 2013].

What is the differential diagnosis?

Be aware that signs of organic disease in infants can be non-specific. Other possible causes of recurrent and prolonged crying include the following; however, this list is not exhaustive:

Basis for recommendation

The information on the differential diagnosis of infantile colic is based on the National Institute for Health and Care Excellence (NICE) clinical guidelines Postnatal care [NICE, 2022] and Food allergy in under 19s: assessment and diagnosis [NICE, 2018], and expert opinion in review articles on infantile colic [DTB, 2013; Johnson, 2015; Daelemans, 2018; Mai, 2018; Sung, 2018] and unexplained crying in infants [Freedman, 2009; Allister, 2014]. It is also pragmatic, based on what CKS considers to be good clinical practice.

Management

Scenario: Management of infantile colic

From birth to 6 months.

How should I manage infantile colic?

Reassure the parents/carers that infantile colic is a common problem that usually resolves by 5 months of age.

  • Advise on sources of information and support, such as:
    • The NHS information leaflet Colic.
    • The Healthier Together information Crying and Colic.
    • The self-help support group Cry-sis for families with excessively crying or sleepless children (website www.cry-sis.org.uk), which has a daily telephone helpline (0800 448 0737) and patient information Coping with colic.
    • The ICON campaign (website www.iconcope.org), which provides advice and support on parental strategies to help cope with infant crying.
    • The family's health visitor or nursery nurse.
  • Advise on strategies that may help to soothe a crying infant, such as:
    • Holding the baby through the crying episode.
    • Reducing environmental stimuli.
    • Gentle motion (such as pushing the pram or rocking the crib).
    • 'White noise' (for example, from a vacuum cleaner or hairdryer).
    • Bathing the infant in a warm bath.
    • Ensuring an optimal winding technique is used during and after feeds.
  • Encourage parents/carers to look after their own wellbeing by:
    • Asking family and friends for support, if possible.
    • Meeting other parents/carers with babies of the same age, to share experiences and access peer support.
    • Resting when the baby is asleep.
    • Putting the baby down in a safe place, such as their cot, if they feel unable to cope with the crying for a few minutes, to allow 'time out'.
  • If the mother is breastfeeding, encourage her to continue wherever possible.
  • Do not recommend the following management strategies for infant crying:
    • Simeticone (such as Infacol®) or lactase (such as Colief®) drops.
    • Maternal diet modification if breastfeeding, or changing the infant milk formula preparation.
    • Probiotic supplements.
    • Herbal supplements.
    • Manipulative strategies such as spinal manipulation or cranial osteopathy.
  • Arrange to review the infant and family, with the time interval and frequency depending on clinical judgement.
    • If symptoms are severe, worsening, or persist after 5 months, consider an alternative underlying cause for symptoms, and seek specialist advice or manage appropriately.
  • Seek specialist advice from a paediatrician or arrange referral, depending on clinical judgement, if:
    • Parents/carers feel unable to cope despite reassurance and advice in primary care.
    • There is suspected faltering growth, or symptoms persist beyond 5 months of age. See the CKS topic on Faltering growth for more information.
    • There is a suspected underlying cause for symptoms which cannot be managed in primary care.

Basis for recommendation

The recommendations on management are largely based on the National Institute for Health and Care Excellence (NICE) clinical guideline Postnatal care [NICE, 2022], the Cochrane systematic reviews Manipulative therapies for infantile colic (Review) [Dobson, 2012], Pain-relieving agents for infantile colic (Review) [Biagioli, 2016], Dietary modifications for infantile colic [Gordon, 2018], Parent training programmes for managing infantile colic [Gordon 2019], and Probiotics to prevent infantile colic [Ong, 2019]; two systematic reviews of treatments for infantile colic [Hall, 2012; Ellwood, 2020], and expert opinion in review articles on infantile colic [DTB, 2013; Waddell, 2013; Akhnikh, 2014; Johnson, 2015; Daelemans, 2018; Mai, 2018; Sung, 2018; Zeevenhooven, 2018], crying in infants [McKenzie, 2013], and infant gastrointestinal symptoms [Vandenplas, 2015a].

Providing reassurance, information, and support
  • These recommendations are largely based on expert opinion in review articles [Sung, 2018; Zeevenhooven, 2018].
    • Parental reasssurance, education, and support are the mainstays of treatment. There is a lack of large, high-quality randomized controlled trials (RCTs) on behavioural, dietary, pharmacological, or alternative management strategies to manage infantile colic [Zeevenhooven, 2018].
Advising on self-help strategies
  • These recommendations are largely based on limited evidence in a Cochrane systematic review of parent training programmes [Gordon 2019], and expert opinion in review articles [DTB, 2013; McKenzie, 2013; Waddell, 2013; Mai, 2018; Sung, 2018; Zeevenhooven, 2018].
    • A Cochrane meta-analysis of 7 studies of parent training programmes (1187 participants), which included advice on soothing and feeding techniques, found limited evidence on their effectiveness and safety, with low-certainty evidence of reduced crying times compared with controls for the intervention group [Gordon 2019].
    • Expert opinion in a review article cites anecdotal evidence of carer strategies to soothe infant crying [Mai, 2018]. A further review article notes conflicting evidence for benefit of holding a baby through a crying episode [Zeevenhooven, 2018].
    • Expert opinion in a review article notes that providing effective coping strategies and methods to soothe the infant are essential to reduce parental stress and anxiety. Behavioural modification may reduce colic symptoms, possibly by increasing carer responsiveness and time spent with the infant [DTB, 2013].
Encouraging parent/carer wellbeing
  • These recommendations are based on expert opinion in a review article [Sung, 2018]. They are also pragmatic, based on what CKS considers to be good clinical practice.
Advising to continue breastfeeding
Treatments not recommended
  • These recommendations are based on four Cochrane systematic reviews [Dobson, 2012; Biagioli, 2016; Gordon, 2018; Ong, 2019], a further systematic review [Ellwood, 2020], and expert opinion in review articles [Daelemans, 2018; Mai, 2018; Sung, 2018].
    • Simeticone is theorized to reduce intraluminal gas in the infant gut; however, a systematic review of two RCTs found conflicting results and no difference in the reduction of colic episodes compared with placebo [Hall, 2012]. This is supported by low-quality evidence in a Cochrane systematic review of three small studies, comparing simeticone with placebo, that found no difference in the reported duration of crying between the treatment and placebo groups, and the studies were at high risk of bias [Biagioli, 2016]. An additional systematic review of interventions for colic found moderate-to-low quality evidence of no benefit or negative effect of simeticone [Ellwood, 2020].
    • The recommendation about lactase drops is based on expert opinion in a review article that states there is inconsistent and conflicting evidence of benefit in treating infantile colic [DTB, 2013]. This is supported by a systematic review of treatments that also found no evidence of benefit [Hall, 2012].
    • The recommendation about not modifying maternal diet or infant milk is based on a Cochrane systematic review of 15 RCTs (n = 1121 infants aged 2–6 weeks) that found a lack of evidence on the effectiveness of dietary modifications for treating infantile colic, and the included studies had small sample sizes, methodological limitations, and were at significant risk of bias [Gordon, 2018]. This approach is supported by expert opinion in review articles [Daelemans, 2018; Sung, 2018].
    • Probiotics are live microorganisms that alter the gut microflora, and may be given as supplements to potentially provide health benefits. A Cochrane meta-analysis of six studies (n = 1886) found no clear evidence that probiotics are more effective than placebo at preventing infantile colic, but daily crying time reduced compared with placebo. The authors reported a limited ability to draw conclusions due to the low certainty of the evidence [Ong, 2019]. An additional systematic review found high-quality evidence that probiotics in breastfed infants reduce crying time [Ellwood, 2020]. Expert opinion in review articles cites emerging evidence in the literature of possible benefit of probiotics such as Lactobacillus reuteri DSM 17938 in the management of colic, particularly in breastfed infants; however, the longterm effects of these supplements are not known, and more good-quality research is needed [Sung, 2018; Zeevenhooven, 2018].
    • The recommendation about herbal supplements is largely based on a Cochrane systematic review that found insufficient evidence to recommend herbal supplements as a treatment option [Biagioli, 2016]. In addition, expert opinion in a review article states that the use of herbal supplements has been associated with adverse effects such as vomiting, sleepiness, and constipation in the infant [DTB, 2013]. This approach is supported by expert opinion in other review articles, which note these preparations have unproven safety and efficacy and an unknown dosing response [Mai, 2018; Sung, 2018].
    • The recommendation about manipulative strategies is largely based on a Cochrane systematic review that found insufficient evidence to support the use of spinal manipulation or cranial osteopathy, as the studies included were small, non-blinded, and at high risk of performance bias [Dobson, 2012]. This approach is supported by an additional systematic review that noted low-to-moderate quality evidence of some benefit of manual therapy, but was unable to comment on the type or quantity of manual therapy that may or may not have had an effect, and recommended more high-quality evidence is needed [Ellwood, 2020].
Arranging follow-up
  • This recommendation is based on expert opinion in a review article [Sung, 2018]. It is also pragmatic, based on what CKS considers to be good clinical practice.
Seeking paediatric advice or arranging referral
  • These recommendations are based on expert opinion in a review article [Zeevenhooven, 2018]. They are also pragmatic, based on what CKS considers to be good clinical practice.

Supporting evidence

This CKS topic is largely based on the National Institute for Health and Care Excellence (NICE) clinical guidelines Postnatal care [NICE, 2022] and Food allergy in under 19s: assessment and diagnosis [NICE, 2018], various Cochrane systematic reviews, and expert opinion in review articles. The rationale for the individual recommendations is discussed in the relevant basis for recommendation sections.

How this topic was developed

This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.

Search strategy

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of infantile colic.

Search dates

June 2017 - November 2022.

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

  • exp Colic/, infantile colic.tw., colic$ ADJ2 infant$.tw.

Sources of guidelines

Sources of systematic reviews and meta-analyses

  • The Cochrane Library:
    • Systematic reviews
    • Protocols
    • Database of Abstracts of Reviews of Effects
  • Medline (with systematic review filter)
  • EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

Sources of randomized controlled trials

  • The Cochrane Library:
    • Central Register of Controlled Trials
  • Medline (with randomized controlled trial filter)
  • EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

Sources of national policy

Patient experiences

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

  • Clinical accuracy.
  • Consistency with other providers of clinical knowledge for primary care.
  • Accuracy of implementation of national guidance (in particular NICE guidelines).
  • Usability.

Principles of the consultation process

  • The process is inclusive and any individual may participate.
  • To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
  • Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
  • Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
  • External reviewers are not paid for commenting on the draft topics.
  • Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
  • All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
  • All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

  • Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
  • Stakeholders identified from the following groups are invited to review draft topics:
    • Experts in the topic area.
    • Professional organizations and societies (for example, Royal Colleges).
    • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
    • Guideline development groups where the topic is an implementation of a guideline.
    • The British National Formulary team.
    • The editorial team that develop MeReC Publications.
  • Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

  • Topic selection
  • Scoping of topic
  • Selection of clinical scenarios
  • First draft internal review
  • Second draft internal review
  • External review
  • Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

  • Animal studies
  • Original research is not written in English

Possible exclusions for reviewed literature:

  • Sample size too small or study underpowered
  • Bias evident or promotional literature
  • Population not relevant
  • Intervention/treatment not relevant
  • Outcomes not relevant
  • Outcomes have no clear evidence of clinical effectiveness
  • Setting not relevant
  • Not relevant to UK
  • Incorrect study type
  • Review article
  • Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

  • Feasibility
    • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
  • Organizational and Financial Impact Analysis
  • Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
    • Eligible population
    • Current interventions
    • Likely uptake of new intervention or recommendation
    • Cost of the current or new intervention mix
    • Impact on other costs
    • Condition-related costs
    • In-direct costs and service impacts
    • Time dependencies
  • Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

  • Personal financial interests
  • Personal family interest
  • Personal non-financial interest
  • Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.

References

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