Trial reportThe Lancet. Global health2017
Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial.
Trial report in The Lancet. Global health, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 28 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Complementary Feeding in Preterm Infants: A Systematic Review.Nutrients · 2020Pooled it
- Iron Deficiency and Iron Homeostasis in Low Birth Weight Preterm Infants: A Systematic Review.Nutrients · 2019Pooled it
- Education of family members to support weaning to solids and nutrition in infants born preterm.The Cochrane database of systematic reviews · 2019Pooled it
- Timing of Complementary Feeding in Preterm Infants and Prevalence of Overweight and Obesity: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Preterm Infants on Early Solid Foods and Neurodevelopmental Outcome-A Secondary Outcome Analysis of a Randomized Controlled Trial.Nutrients · 2024Trial
- Preterm Infants on Early Solid Foods and Iron Status in the First Year of Life-A Secondary Outcome Analysis of a Randomized Controlled Trial.Nutrients · 2022Trial
- Randomized Controlled Trial of Two Timepoints for Introduction of Standardized Complementary Food in Preterm Infants.Nutrients · 2022Trial
- Nutritional intake and growth in very low birth weight infants: a comparison of standardized versus parent-led complementary feeding.European journal of clinical nutrition · 2026Article
- Do children's feeding practices affect growth outcomes in sub-Saharan Africa? A multi-country study.Journal of health, population, and nutrition · 2026Article
- Parents' Perspectives and Processes During Weaning for Preterm-Born Children: A Qualitative Study in Japan.Journal of nursing management · 2026Article
- Infant gut microbiome reprogramming following introduction of solid foods (weaning).Gut microbes · 2025Review
- Exploring mothers' and grandmothers' perceptions of animal-source complementary foods in the diets of young children in The Gambia: A qualitative study.Wellcome open research · 2025Article
- Observational
- Introduction of Solid Foods in Preterm Infants and Its Impact on Growth in the First Year of Life-A Prospective Observational Study.Nutrients · 2024Observational
- Article
- [Introduction of complementary feeding and associated factors in preterm and low birthweight newborns: a prospective cohort study].Cadernos de saude publica · 2024Article
- Diagnosis and management of mineral and bone disorders in infants with CKD: clinical practice points from the ESPN CKD-MBD and Dialysis working groups and the Pediatric Renal Nutrition Taskforce.Pediatric nephrology (Berlin, Germany) · 2023Review
- Complementary feeding in preterm infants: a position paper by Italian neonatal, paediatric and paediatric gastroenterology joint societies.Italian journal of pediatrics · 2022Review
- Complementary Feeding in the Preterm Infants: Summary of Available Macronutrient Intakes and Requirements.Nutrients · 2020Article
- Review
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
14 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEvidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation.
methodsIn this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1) at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group), or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group), using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31-33 weeks). Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ
findingsBetween March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up) and eight infants in the 6 month group (two deaths, six lost to follow-up) were excluded from analysis of primary outcome. There was no difference in WAZ
interpretationAlthough there was no evidence of effect for the primary endpoint of WAZ
fundingIndian Council of Medical Research supported the study until Nov 14, 2015. Subsequently, Shuchita Gupta's salary was supported for 2 months by an institute fellowship from All India Institute Of Medical Sciences, and a grant by Wellcome Trust thereafter.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.