Evidence map›Paper›PMID 37111119›Full record

Trial reportNutrients2023

Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

Lindsey Otten, Elisabeth Schelker, Hanna Petersen, Antonia Nomayo, Manja Fleddermann, Bianca M Arendt, Theresa Britzl, Elisabeth M Haberl, Frank Jochum, HASI Study Group

Erratum issuedOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nutrients, 2023. 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 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% of its field
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  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. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Lindsey OttenDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589 Berlin, Germany.
Elisabeth SchelkerDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589 Berlin, Germany.
Hanna PetersenDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589 Berlin, Germany.
Antonia NomayoDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589 Berlin, Germany.
Manja FleddermannHiPP GmbH & Co. Vertrieb KG, Georg-Hipp-Str. 7, 85276 Pfaffenhofen an der Ilm, Germany.
Bianca M ArendtHiPP GmbH & Co. Vertrieb KG, Georg-Hipp-Str. 7, 85276 Pfaffenhofen an der Ilm, Germany.
Theresa BritzlHiPP GmbH & Co. Vertrieb KG, Georg-Hipp-Str. 7, 85276 Pfaffenhofen an der Ilm, Germany.
Elisabeth M HaberlHiPP GmbH & Co. Vertrieb KG, Georg-Hipp-Str. 7, 85276 Pfaffenhofen an der Ilm, Germany.
Frank JochumDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589 Berlin, Germany.
HASI Study Group
Waldkrankenhaus Protestant Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We aimed to demonstrate that healthy term infants experience noninferior growth with infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF). This prospective, randomised, double-blind, parallel-group, controlled, multicentre trial included healthy term infants who were exclusively formula-fed. Infants ≤ 25 days of age received eHF or CF for at least three months up to 120 days of age, with a follow-up until 180 days of age. A reference group included exclusively breastfed infants (BF). Of 318 infants randomised, 297 (148 CF, 149 eHF) completed the study per protocol. Weight gain up to 120 days of age was noninferior (margin -3.0 g/day) in eHF (28.95 (95% CI: 27.21; 30.68) g/day) compared to CF (28.85 (95% CI: 27.10; 30.61) g/day) with a difference in means of 0.09 g/day and a lower limit of the one-sided 97.5% CI of -0.86 g/day (

Indexed as

Infant FormulaMilk HypersensitivityAnimalsDouble-Blind MethodFemaleHumansInfantProspective StudiesWeight GainWhey ProteinsWhey Proteinsbreastfedextensively hydrolysed whey proteininfant formulainfant growthinfant nutritioninfant weightneonatalprotein hydrolysate

Identifiers

PMID37111119
PMCPMC10146495
OpenAlexW4365509439

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.