Lucassen 2000.
| Methods | Randomised, double‐blind, parallel trial with 2 treatment groups | |
| Participants |
Sample size: 38 infants (5 dropouts: 2 from illness, 2 from non‐compliance, and 1 referred because of worsening symptoms – 3 intervention, 2 control) Setting: infants recruited from community‐based, well‐child clinics in 6 regions of an area of Holland with 7500 births annually, co‐ordinated by the Academic Hospital of Vrije University, Amsterdam, The Netherlands Sex: 19 boys (50%) Mean age: 7.7 weeks (SD not reported, range 6.4 to 8.9) intervention; 8.3 weeks (SD not reported, range 6.6 to 10.1) control Mean weight: 4.5 kg (4.2 to 4.8) intervention; 4.9 kg (4.3 to 5.6) control Mean duration of colic (baseline): 403 min/day (341 to 466) intervention; 328 min/day (291 to 366) control Mean crying (baseline): 299 min/day (251 to 347) intervention; 267 min/day (226 to 307) control Feeding: fully formula fed or fed with mix of breast and formula, but the paper neither specifies how many babies were also receiving breast milk, nor treated the receipt of breast milk as a confounding factor Birth order: not reported Inclusion criteria: infants with good medical condition on examination by clinic doctor, thriving, formula fed (at least 1 formula feed per day), good feeding technique, < 6 months old, crying > 3 h/d on at least 3 d/week Exclusion criteria: history of anaphylaxis to cows' milk, previous trial of hypoallergenic feeding, refusal to give informed consent, communication problems, referred to paediatrician, no crying problem anymore, other illness, other advice from own doctor, refusal to keep diary |
|
| Interventions |
Intervention (n = 23): Nutricia whey hydrolysate formula Control (n = 20): Nutricia standard formula Duration: 1‐week study after baseline for one week |
|
| Outcomes | Parents instructed on the use of a 24‐h diary and questionnaire to assess minutes of crying per 24 h, which included the question, "Do you know which formula your infant has been using this week?" (quote) to test for adequate blinding. Evaluation of results to include proportion of infants who, after the intervention, would no longer meet the inclusion criteria | |
| Notes |
Study start and end dates: August 1994 (start) to October 1996 (end) COIs: Nutricia provided the formula Funding source: Praeventie Fonds – the Dutch National Preventative Fund Adverse effects: none reported Comments: none |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: randomised to intervention or control group by SPSS Inc, Chicago |
| Allocation concealment (selection bias) | Low risk | Comment: response from study author as follows (quote), "a box containing the formula was sent to each participating centre. Each box contained 16 cans of formula of which 8 contained hypo‐allergenic formula and 8 normal formula (of which taste and smell were changed in the direction of hypoallergenic formula). All cans were identical and contained a sticker with a number. Each set of two cans had the same number (so it was impossible to provide one can with hypoallergenic formula and one can with control formula to the same infant). The local centre distributed the cans, two for each infant. The persons at the local centre were completely unaware of the codes. The codes were generated with a random numbers list" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: study author responded. Blinding of parents was made possible by changing the taste and smell of the control formula in the direction of taste and smell of the hypoallergenic formula |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: study author responded. Blinding of the parents was made possible by changing the taste and smell of the control formula in the direction of taste and smell of the hypoallergenic formula |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: accounted for all participants |
| Selective reporting (reporting bias) | Low risk | Comment: study author contacted and we were informed that there were no adverse effects |
| Other bias | Unclear risk | Comment: Nutricia provided the formula. Contact from the study author tells us that Nutricia did not play any role except in the provision of the formulas; they were not involved in writing or checking the manuscript |