Parent training programmes for managing infantile colic

Abstract

Background: Infantile colic has an effect on both infants and their parents, who become exhausted and concerned as they attempt to comfort their child. Common approaches have focused upon physical treatments to reduce symptoms, with inconclusive evidence as to their effectiveness. An alternative approach seeks to provide training, support and psychological interventions for parents. This approach is known as parent training programmes. Programmes can include soothing techniques, advice on feeding or normalisation material in any form. The teaching format can vary including face-to-face courses, online learning, printed materials, home visits and remote support and counselling. Here, we aim to collate the evidence on the effectiveness of these interventions and examine their effectiveness at reducing infantile colic symptoms and parental anxiety levels, and their safety.

Objectives: 1. To evaluate the effectiveness and safety of parent training programmes for managing colic in infants under four months of age. 2. To identify the educational content and attributes of such published programmes.

Search methods: In June 2019 we searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers. We also handsearched conference abstracts, inspected the references of included studies and contacted leaders in the field for more trials.

Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs investigating the effectiveness of any form of parental training programmes, alone or in combination, versus another intervention(s) or control, on infantile colic.

Data collection and analysis: Two authors independently selected studies for inclusion, extracted data, and assessed the risk of bias within the included studies. We used Review Manager 5 to analyse the data. We assessed the certainty of the evidence using GRADE methodology.

Main results: Our search found 6064 records from which we selected 20 for full-text review. From these, we identified seven studies with 1187 participants that met our inclusion criteria. All of the studies included infants under the age of four months suffering from infantile colic. Four studies were conducted in the USA, one in Canada, one in the Netherlands and one in Iran. Four studies stated their funding sources, which included national research institutes, foundations and nutritional companies. Five studies assessed parent training versus a control group that received reassurance or routine care; and of these, one study was three-armed and also examined the effectiveness of using a specialised baby seat. One study examined parent training programmes against a milk-exclusion diet and one study assessed a parent training programme versus the same parent training programme plus swaddling. The duration of the interventions varied, with the shortest being six days and the longest being three months. Generally, most studies had low participant numbers and were at high risk of bias, prone to selection bias, performance bias, and the placebo effect. We could not complete the planned qualitative analysis (objective 2) due to lack of data in study reports and no further information being supplied by authors on request. Instead, we completed a descriptive content analysis with the limited information available. The parent training interventions were found to focus on one or a combination of the following: soothing techniques for crying infants (six studies); general care advice, including sleep (four studies); feeding advice (two studies); stress reduction and empathic programme for parents (two studies); and positive play interaction advice (one study). One study taught 'kangaroo care', a specific form of skin-to-skin cuddling. The control groups consisted of reassurance (two studies), advice to rock the infant in the crib (one study), or no intervention (two studies). Parent training versus control We conducted a meta-analysis using data from three studies (157 infants) that assessed the primary outcome of 'crying time at completion of study period'. Parent training was more effective than control: mean difference (MD) -113.58 m/d, 95% confidence interval (CI) -144.19 m/d to -82.96 m/d; low-certainty evidence (downgraded due to imprecision and some concerns with risk of bias). Parent training versus specialised baby seat One study (38 participants) found no difference in mean crying time at completion between the parent training group and the specialised baby seat group, but did not report specific figures. Parent training versus a milk-exclusion/soy milk formula One study (20 participants) comparing parent training with a milk-exclusion/soy milk formula found crying time at completion of the study to be 2.03 hours versus 1.08 hours, respectively. Parent training versus parent training plus swaddling One study (398 participants) comparing parental training with the same intervention plus training on how to swaddle an infant did not report separate data for each group. No adverse effects were reported, but these were not explicitly reported in any study.

Authors' conclusions: There is limited evidence on the effectiveness and safety of parent training programmes for managing infantile colic. Despite a single meta-analysis showing that parent training may reduce crying times for infants, compared to control, the certainty of the evidence was low. Evidence for other comparisons was sparse. We were unable to identify comprehensively the educational content and attributes of the included programmes due to a lack of information in study reports. Further RCTs are needed: they should define interventions clearly to ensure replicability, address all appropriate outcome measures, and minimise risk of bias in order to assess definitively the role of parent training programmes in managing infantile colic.

Conflict of interest statement

MG has received unrestricted travel grants in the last three years from Ferring Pharmaceuticals, Tillots Pharma AG, BioGaia and Synergy Pharma to attend meetings to present results of previous works. They have had no input or involvement in any aspect of the review process during this or previous systematic reviews carried out by MG. MG declares that whilst Ferring and BioGaia produce products that can be used for colic, they were not involved in any of the studies in the scope of this review. MG been involved as an author on other Cochrane Reviews, including 'Bowel preparation for paediatric colonoscopy' (Gordon 2012) and 'Probiotics for maintenance of remission in ulcerative colitis' (Naidoo 2011). MG is a paediatrician with an interest in gastroenterology. This involves seeing patients referred with infantile colic and managing them in line with current accepted evidence‐based practice. MG is also an NIHR Cochrane programme grant holder in the UK.

Shel Banks (SB) is being paid as a Research Assistant for this review from Blackpool Teaching Hospitals NHS Foundation Trust. SB is Chair of the Local Infant Feeding Information Board (LIFIB) — providing syntheses of evidence‐based information on infant feeding topics for health professionals. SB works as a Consultant for LIFIB and the Sudden Unexpected Death of a Child Prevention Team, and until March 2016, this post was funded by money from the local authority via Breastfeeding Network and SB was paid by the hour. SB also works as an Internationally Board Certified Lactation Consultant in private practice. SB declares that neither she personally nor any of the entities she represents take funding of any kind from any commercial interests in infant feeding or early years and that she works completely within the professional code of ethics as an Internationally Board Certified Lactation Consultant.

Jesal Gohil (JG) has no declarations of interest. He is currently a core medical trainee.

Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Figures

1

Study flow diagram.

2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

3

Forest plot of comparison: 1 Parent training versus control, outcome: 1.1 Crying time at completion (minutes/day).

4

Forest plot of comparison: 1 Parent training versus control, outcome: 1.2 Crying time at completion (minutes/day): sensitivity analysis using the fixed‐effect model.

1.1. Analysis

Comparison 1 Parent training versus control, Outcome 1 Crying time at completion (minutes/day).

1.2. Analysis

Comparison 1 Parent training versus control, Outcome 2 Crying time at completion (minutes/day): sensitivity analysis using the fixed‐effect model.

References

References to studies included in this review Dihigo 1998 {published data only}

Keefe 2006 {published data only} Parkin 1993 {published data only} Saeidi 2013 {published data only} Salisbury 2012 {published data only} Taubman 1988 {published data only} Van Sleuwen 2006 {published data only} References to studies excluded from this review Barr 2009 {published data only} Cook 2012 {published data only} Lim 2013 {published data only} McRury 2010 {published data only} Smith 2004 {published data only} St James‐Roberts 2001 {published data only} Taubman 1984 {published data only} Van den Boom 1994 {published data only} Wolke 1994 {published data only} References to studies awaiting assessment Cook 2015 {published data only} Additional references Ali 2012 Arslanoglu 2012 Axelsson 1986 Banks 2016 Barr 1991 Bryanton 2013 Campbell 1989 Campbell 2000 Chandran 2014 Clifford 2002 De Weerth 2013 Deeks 2011 Dobson 2012 Dupont 2010 Estep 2000 Freedman 2009 Furlong 2012 Garrison 2000 Gordon 2011 Gordon 2012 Gordon 2013 Gordon 2018 GRADEpro GDT [Computer program] Gupta 2007 Guyatt 2008 Haji 2013 Hall 2012 Harb 2015 Heine 2013 Heine 2014 Higgins 2011a Higgins 2011b Higgins 2011c Hill 1995 Hill 2000 Hill 2005 Hiscock 2014 Huhtala 2000 Hyams 1989 Hyman 2006 Iacono 1991 Iacono 2005 Iacovou 2012 Indiro 2014 Infante 2011 Jakobsson 1983 Jakobsson 2000 Karp 2003 Landgren 2010a Landgren 2010b Lefebvre 2008 Levy 2015 Lindberg 1999 Lothe 1982 Lothe 1989 Lucas 1998 Lucassen 2000 Markestad 1997 McKenzie 1991 Merras‐Salmio 2013 Metcalf 1994 Miller 1990 Moher 2009 Moore 1998 Mostafa 2008 Naidoo 2011 NICE CKS 2014 Norcini 2011 Nvivo 2015 [Computer program] Olafdottir 2001 Oozeer 2013 Oshikoya 2009 Oxman 1992 Perry 2011 Pitkin 1999 Reijneveld 2001 Reinthal 2008 Review Manager 2014 [Computer program] Romanello 2013 Rosen 2007 Saps 2011 Savino 2001 Savino 2002 Savino 2005 Savino 2006 Savino 2007 Savino 2010 Savino 2012 Savino 2014a Savino 2014b Schach 2002 Schmitt 1987 Shannon 1921 Skjeie 2013 St James‐Roberts 1991 Sterne 2011 Thomas 2010 Unnebrink 2001 UpToDate 2016 UpToDate Patient Information Tips Walter 2000 Wessel 1954 Wolfe 1994 Wright 2003 Yusuf 1991 Zwi 2011 References to other published versions of this review Thomas 2016