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. 2018 Oct 11;2018(10):CD011029. doi: 10.1002/14651858.CD011029.pub2

Kearney 1998.

Methods Randomised, double‐blind, cross‐over trial with 2 treatment groups
Participants Sample size: 13 infants (0 dropped out)
Setting: general practices and paediatric clinics in Cork, Ireland
Sex: 9 boys (69%) 4 girls (31%)
Mean age: 53.5 days (SD 26.2, range 23 to 113 days)
Mean weight: not reported
Mean duration of colic (baseline): not reported
Mean crying (baseline): not reported
Feeding: formula fed (100%)
Birth order: not reported
Inclusion criteria: formula‐fed infants with colic symptoms using a modified Wessel's criteria: full force crying for ≥ 3 h/d for ≥ 3 d/week. Their definition did not require crying of 3 weeks or more
Exclusion criteria: 'otherwise well' (quote)
Interventions Intervention (n = not reported): lactase (Lactaid) drops; 3 drops added to each feed, which was then refrigerated for 24 h before feeding to the baby
Control (n = not reported): placebo supplied by manufacturer for lactase (Lactaid) drops; 3 drops added to each feed, which was then refrigerated for 24 h before feeding to the baby
Duration: 1 week
Outcomes Parents asked to keep a diary containing information about baby's crying time, stool habit and details of volumes, strength and type of formula
Notes Study start and end dates: not known
COIs: none reported
Funding source: Mediplan and Myplan, who make the lactase product Lactaid, which was used as the intervention
 Adverse effects: none reported
Comments: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "random permutated blocks of size four to ensure that the numbers of babies assigned to the two treatment orders were fairly even"
Allocation concealment (selection bias) High risk Comment: no details. Wrote to study author but received no response
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "preparations given in bottles marked week 1 and week 2 to ensure the double blind nature of the trial"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: no details at all. Wrote to study author but received no response
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "13 babies completed the trial"
Comment: does not say how many began the trial
Selective reporting (reporting bias) Low risk Comment: results from each cross‐over arm are lumped together in the data reports so meta‐analysis not possible
Adverse effect data given
Other bias High risk Comment: funded by industry and no response received from study author to confirm level of involvement