Trial reportBMC pediatrics2021
Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial.
Trial report in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01354366 (The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants), which is not on this map. Cited by 5 papers.
What it found
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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.
The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
Who cites it
5 citing papers in PubMed.
- Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT.BMC pediatrics · 2026Trial
- New infant formulas for healthy term infants: A randomized, controlled, double-blind, multicenter, non-inferiority design safety study.PloS one · 2025Trial
- Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.Nutrients · 2023Trial
- Evolutive Study of Dietary Aspects and Intestinal Microbiota of Pediatric Cohort with Cow's Milk Protein Allergy.Children (Basel, Switzerland) · 2024Article
- The use of amino acid formulas in pediatric patients with allergy to cow's milk proteins: Recommendations from a group of experts.Frontiers in pediatrics · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOptimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein.
methodsIn this prospective, multi-center, double-blind, controlled, parallel group study, infants were randomized to receive a marketed EH casein infant formula at 2.8 g protein/100 kcal (Control) or one of two investigational formulas: EH casein formula at 2.4 g protein/100 kcal (EHF) or AA-based formula at 2.4 g total protein equivalents/100 kcal (AAF). Control and EHF each had 2 × 10
resultsNo group differences in weight or length growth rate from 14 to 120 days were detected. With the exception of significant differences at several study time points for males, no group differences were detected in mean head circumference growth rates. However, mean achieved weight, length, and head circumference demonstrated normal growth throughout the study period. No group differences in achieved weight or length (males and females) and head circumference (females) were detected and means were within the WHO growth 25th and 75th percentiles from 14 to 120 days of age. With the exception of Day 90, there were no statistically significant group differences in achieved head circumference for males; means remained between the WHO 50th and 75th percentiles for growth at Days 14, 30, and 60 and continued along the 75th percentile through Day 120. No differences in study discontinuation due to formula were detected. The number of participants for whom at least one adverse event was reported was similar among groups.
conclusionsThis study demonstrated hypoallergenic infant formulas at 2.4 g protein/100 kcal were safe, well-tolerated, and associated with appropriate growth in healthy term infants from 14 to 120 days of age.
trial registrationClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT01354366 . Registered 13 May 2011.
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