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. 2019 Jun 17;2019(6):CD011695. doi: 10.1002/14651858.CD011695.pub2

Moursi 2003.

Methods RCT
Sample size: 75
Inclusion criteria: 10 weeks old at start of study, singletons; birth weight > 2500 g; brought up and breastfed by their mothers at home; weight‐for‐length z‐score > –2 at 16 weeks; not hospitalised for serious illnesses; no malformations; the mother or carer should not have intended to be absent for more than 1 week during the study; and parents had to consent to the presence of a trained assistant in their house for 24 hours when the child reached the age of 16 and 24 weeks and also accept weekly visits for collection of morbidity data.
Exclusion criteria: violation of any of the inclusion criteria.
Participants Children
Age: 4.5 months
Country: Congo Brazzaville
Setting: in the borough of Poto‐Poto in Brazzaville where the prevalence of stunting of children 2 years old was high (15.5%)
Interventions Type: supplementation of a maize/soy‐based flour that contained amylase. Mothers were shown in each group in 1 single demonstration how to prepare the gruel of similar consistency to the ones they were used to preparing.
Urban specificity: none
Level of factors tackled: individual
Delivery: investigators
Duration (years): 0.7
Comparison:
IG: maize/soy‐based flour that contained amylase
CG: similar flour that did not contain amylase
Measurement: 10, 16, 24, and 32 weeks of age grouped in 10–15, 16–23, 24–31, and 16–31 weeks of age. Consumption of complementary foods was assessed at the age of 24 weeks using a 24‐hour observed weighed food record.
PROGRESS at baseline: SES data collected but nutritional status data not disaggregated by any of them.
Outcomes Length velocity (cm/month), WFA, WFH, infant and young children practices and dietary intake, rate of ill days, incidence of diseases
Notes No funding information
Impact of the intervention:
IG: 16–31 weeks of age: 1.88, SD 0.07; 24–31 weeks of age: 1.85, SD 0.12
CG: 16–31 weeks of age: 1.66, SD 0.07; 24–31 weeks of age: 1.34, SD 0.13
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Paper stated that infants were randomly assigned on an individual basis to the CG or IG but no information was given on how that random allocation was achieved.
Allocation concealment (selection bias) High risk No information given.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No information provided regarding any blinding of participants or personnel to allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No information provided regarding any blinding of the outcome assessment. Dietary intake could be subject to bias if not blinded and this is a key outcome.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 80 infants initially participated in the study but 5 (3 in the IG and 2 in the CG) dropped out after the age of 16 weeks. Of those who dropped out, 4 did so because their parents moved away and 1 child died.
Selective reporting (reporting bias) High risk No published protocol to establish this risk and the methods were not clear on what the specific measures of outcome to be assessed would be.
Other bias High risk Likely that all participants feed unobserved. There was only a single point of assessment on 1 day of dietary intake. There was no high‐quality monitoring of ongoing compliance with use of the gruels beyond 1 × 24‐hour assessment. The study was funded by the Institute de Recherche pour le Developpement (IRD or ex‐ORSTROM). Unclear if the participants benefited from other ongoing interventions during the study period.
Similarity of outcome measures at baseline Unclear risk Insufficient information to assess this risk.
Similarity of baseline characteristics Unclear risk Insufficient information to assess this risk.
Protection against contamination Unclear risk Insufficient information to assess this risk.