Evidence map›Paper›PMID 19543114›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2009

Randomized controlled trial of feeding a concentrated formula to infants born to women infected by human immunodeficiency virus.

Harland S Winter, James M Oleske, Michael D Hughes, Ross E McKinney, Carol Elgie, Christine Powell, Lynette Purdue, Ana M Puga, Eleanor Jimenez, Gwendolyn B Scott and 3 more

Open access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 38% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. 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

13 authors at 10 institutions in 3 countries.

Harland S WinterPediatric Gastroenterology and Nutrition Unit, MassGeneral Hospital for Children, Boston, MA 02114, USA. hwinter@partners.org
James M Oleske
Michael D Hughes
Ross E McKinney
Carol Elgie
Christine Powell
Lynette Purdue
Ana M Puga
Eleanor Jimenez
Gwendolyn B Scott
Maria Leticia Santos Cruz
Jack Moye
Pediatric AIDS Clinical Trials Group Protocol 247 Study Team
Children's Diagnostic & Treatment Center · USDuke Medical Center · USFrontier Science & Technology Research Foundation · USHarvard University · USHarvard University Press · USHospital Federal dos Servidores do Estado · BRNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USSan Juan City Hospital · PRUniversity of Miami · US

Funding

International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
PEDIATRIC AND MATERNAL HIV CLINICAL TRIALS NETWORK-275933162N01HD033162 · NICHD · WESTAT, INC. · 1993 to 2003
$15.0M
NICHD INTERNATIONAL PEDIATRIC AND PERINATAL HIV STUDIES NETWORK COORDI-275033345N01HD033345 · NICHD · WESTAT · PI NESEL, CAROL · 2004 to 2006
–
NIAID NIH HHS AI-41110NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068632NICHD NIH HHS N01 HD033345NICHD NIH HHS N01-HD-3-3162NICHD NIH HHS N01-HD-3-3345
6 · The paper itself

Abstract

objectiveWe tested the hypothesis that concentrated formula (CF) begun within the first 2 weeks of life increases growth in infants born to human immunodeficiency virus (HIV)-infected mothers. MATERIALS AND

methodsHIV-exposed infants from the United States, the Bahamas, and Brazil were randomized in a double-blind, controlled trial to receive either a CF (87 kcal/100 mL [26 kcal/oz]) or a standard formula (SF; 67 kcal/100 mL [20 kcal/oz]) for 8 weeks. This article presents results for infants who were not determined to be HIV infected based on testing at 4 weeks. Primary outcomes were safety, tolerability, and growth in weight and length.

resultsTwo thousand ninety-seven infants were enrolled, of whom 1998 were uninfected and had study formula dispensed. At weeks 4 and 8, uninfected infants receiving CF showed higher energy intake than those who were receiving SF (P < 0.001). By week 8, uninfected infants assigned to CF weighed more than infants receiving SF. There were no consistent differences in measures of tolerability, and rates of discontinuation or perceived formula intolerance were similar between treatment groups.

conclusionsA CF is well tolerated and results in increased weight gain compared with SF. Until the HIV status of an infant is reliably determined, early introduction of a CF in HIV-exposed children may have beneficial effects on growth. The role of early nutritional intervention remains to be determined for individuals living in countries with endemic malnutrition for whom formula feeding is a viable option.

Indexed as

Energy IntakeHIV InfectionsInfant FormulaPregnancy Complications, InfectiousWeight GainAnimalsBahamasBrazilDouble-Blind MethodFemaleHumansInfantInfant, NewbornMilkPregnancyUnited States

Identifiers

PMID19543114
PMCPMC3934421
OpenAlexW2046076486

What OpenQuestion holds

Textmetadata
LicenceTDM
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.