Evidence map›Paper›PMID 31331065›Full record

Trial reportNutrients2019

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants.

Jacques Rigo, Stefanie Schoen, Marc Verghote, Bart van Overmeire, Wivinne Marion, Marieke Abrahamse-Berkeveld, Philippe Alliet

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. A Systematic Review to Reassess the Formula for Early Life Growth.Advances in nutrition (Bethesda, Md.) · 2026
    Pooled it
  2. Trial
  3. Trial
  4. Hypoallergenicity assessment of an extensively hydrolyzed whey-protein formula in cow's milk allergic infants.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2022
    Trial
  5. Trial
  6. A Scoping Review of Instruments Used to Measure Weight and Body Composition in Infants Under 1 Year.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
    Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jacques RigoDepartment of Pediatrics, Neonatal Unit, University of Liege, CHU-CHR Citadelle, Boulevard du XIIème de Ligne 1, 4000 Liege, Belgium.
Stefanie SchoenDanone Nutricia Research, Uppsalalaan 12, 3584 CT Utrecht, The Netherlands.
Marc VerghoteDepartment of Pediatrics, CHR Namur, Avenue Albert Premier 185, 5000 Namur, Belgium.
Bart van OvermeireDepartment of Neonatology, ULB Erasme, Lenniksebaan 808, 1070 Brussels, Belgium.
Wivinne MarionDepartment of Neonatology, Clinique Saint Vincent, Rue François Lefèbre 207, 4000 Rocourt, Belgium.
Marieke Abrahamse-BerkeveldDanone Nutricia Research, Uppsalalaan 12, 3584 CT Utrecht, The Netherlands.
Philippe AllietDepartment of Pediatrics, Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium. dr.philippe.alliet@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants. Fully formula-fed infants were randomised ≤14 days of age to receive a partially hydrolysed whey formula with 2.27 g protein/100 kcal (pHF2.27) or the same formula with 1.8 g or 2.0 g protein/100 kcal (pHF1.8 and pHF2.0) until 4 months of age. The primary outcome was equivalence in daily weight gain within margins of ± 3 g/day; comparison with WHO Child Growth Standards; gastrointestinal tolerance parameters and number of (serious) adverse events were secondary outcomes. A total of 207 infants were randomised, and 61 (pHF1.8), 46 (pHF2.0) and 48 (pHF2.27) infants completed the study per protocol. Equivalence in daily weight gain was demonstrated for the comparison of pHF1.8 and pHF2.27, i.e., the estimated difference was -1.12 g/day (90% CI: [-2.72; 0.47]) but was inconclusive for the comparisons of pHF2.0 and pHF2.27 with a difference of -2.52 g/day (90% CI: [-4.23; -0.81]). All groups showed adequate infant growth in comparison with the World Health Organization (WHO) Child Growth Standards. To conclude, the evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants.

Indexed as

Diet, Protein-RestrictedWeight GainBelgiumBirth WeightDouble-Blind MethodFemaleHumansHydrolysisInfantInfant FormulaInfant, NewbornInfant Nutritional Physiological PhenomenaMaleNutritive ValueProspective StudiesWheyWhey Proteinsgastrointestinal tolerancegrowthinfant formulapartially hydrolysedproteinsafety

Identifiers

PMID31331065
PMCPMC6682927

What OpenQuestion holds

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Registered trials

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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.