Hill 1995.
| Methods | Double‐blind, randomised, placebo‐controlled trial over 1 week with 4 treatment groups | |
| Participants |
Sample size: 38 formula‐fed and 77 breastfed infants (36 dropped out – 18 in each group) Setting: metropolitan, community‐based, well‐infant centres, Melbourne, Australia Sex: not reported Mean age: not reported (SD not reported) Mean weight: not reported Mean duration of colic (baseline): 5.1 h/d (SD 3.0) intervention, 5.9 h/d (SD 3.1) control Mean crying (baseline): The mean day 1 total distress score for the intervention diet group was 330.5 minutes, and for the control diet group, 268.0 minutes (P = 0.12) Feeding: formula fed (33%; n = 38) Inclusion criteria: aged 4‐16 weeks, uncomplicated pregnancy of more than 37 weeks' duration, uneventful perinatal period, colic definition 'rule of three', and otherwise healthy except for colic. Also included those on medication for colic, as long as medications continued throughout the trial Exclusion criteria: not reported |
|
| Interventions | Intervention (n = 54): mothers of breastfed babies given a hypoallergenic or anti‐oligogenic diet (excluding food dyes, additives, preservatives, milk, egg, wheat or nuts), and formula‐fed babies provided with a casein based hydrolysate formula (Pregestamil) Control (n = 61): mothers of breastfed babies given a standard oligoantigenic diet (avoiding food dyes, additives, preservatives), and formula‐fed babies given standard formula (Enfamil Reduced Iron) Duration: 1 week | |
| Outcomes | Parents instructed in the use of a 24‐h distress score chart, which they were asked to complete on day 1 and day 8 of the trial, with distress marked in min/h | |
| Notes |
Study start and end dates: not reported; however, paper does report that the original study was intended to be 12 months, but that it was harder to recruit than they had expected and the study was finally closed after 3 years COIs: none reported Funding source: supported by a grant from Mead Johnson Adverse effects: none reported Comments: none |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: says it is randomised. Wrote to study author but received no response |
| Allocation concealment (selection bias) | Low risk | Comment: sealed envelopes for assignment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: double‐blind – identical sealed tins |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: as above |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all patient outcomes described |
| Selective reporting (reporting bias) | High risk | Comment: no specific mention or reporting of adverse effects. No response received from study author |
| Other bias | High risk | Comment: supported by a grant from Mead Johnson. No further details of involvement and no response received from study author |