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 |