Evidence map›Paper›PMID 19545360›Full record

Trial reportNutrition journal2009

Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants.

Carol Lynn Berseth, Susan Hazels Mitmesser, Ekhard E Ziegler, John D Marunycz, Jon Vanderhoof

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 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.

NCT00666120 nacompletednot on this map

Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

TypeinterventionalSponsorMead Johnson NutritionRan2005 to 2006Enrolled333ConditionsHealthy Term Infants Solely Formula FedArmsEnfamil LIPIL with iron, Good Start Supreme with DHA and ARA
NCT01673165 nacompletednot on this mapstarted 2012, after this paper: background citation

A Comparison of the Effectiveness of Fortified Skimmed Mother's Milk Versus Specialized Formula in the Management of Chylous Effusion in Infants Following Cardiothoracic Surgery

TypeinterventionalSponsorOregon Health and Science UniversityRan2012 to 2015Enrolled17ConditionsChylous Pleural Effusion Following Cardiothoracic SurgeryArmsSkimmed mother's milk, Specialized Formula
NCT03488758 nacompletednot on this mapstarted 2018, after this paper: background citation

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

TypeinterventionalSponsorCentre Hospitalier Intercommunal CreteilRan2018 to 2021Enrolled73ConditionsFeeding Behavior, Feeding, BottleArmsCMF, GMF
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
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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

5 authors.

Carol Lynn BersethMead Johnson Nutrition, 2400 W, Lloyd Expressway, Evansville, Indiana 47721, USA. carol.berseth@mjn.com
Susan Hazels Mitmesser
Ekhard E Ziegler
John D Marunycz
Jon Vanderhoof

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life.

methodsThe objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy, term infants. Infants (335) were randomized to receive either a standard intact cow milk protein formula (INTACT) or a partially hydrolyzed cow milk protein formula (PH) in a 60 day non-inferiority trial. Discontinuance due to study physician-assessed formula intolerance was the primary outcome. Secondary outcomes included number of infants who discontinued for any reason, including parent-assessed.

resultsFormula intolerance between groups (INTACT, 12.3% vs. PH, 13.7%) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance. Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants (14.4 vs.11.1%) was significantly different (P = 0.001).

conclusionThis study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy, term infants over a 60-day feeding trial, suggesting nonstandard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants. Parents frequently perceived infant behavior as formula intolerance, paralleling previous reports of unnecessary formula changes.

trial registrationclinicaltrials.gov: NCT00666120.

Indexed as

Infant, NewbornInfant Nutritional Physiological PhenomenaHumansInfant BehaviorInfant FormulaMilk HypersensitivityParentsPerceptionProtein HydrolysatesProtein Hydrolysates

Identifiers

PMID19545360
PMCPMC2708183

What OpenQuestion holds

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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.