Evidence map›Paper›PMID 29750766›Full record

Trial reportThe Pediatric infectious disease journal2018

Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results From the HPTN 040/PACTG 1043 Trial.

Nava Yeganeh, D Heather Watts, Jiahong Xu, Tara Kerin, Esau C Joao, Jose Henrique Pilotto, Gerhard Theron, Glenda Gray, Breno Santos, Rosana Fonseca and 8 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in The Pediatric infectious disease journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06971445 (Effect of Polyunsaturated Fatty Acids Omega-3 Supplementation on Pregnancy Outcomes and Inflammation Markers in Pregnant Women HIV+, With Antiretroviral Therapy, Randomized Clinical Trial.), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.8field-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.

NCT06971445 naenrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Effect of Polyunsaturated Fatty Acids Omega-3 Supplementation on Pregnancy Outcomes and Inflammation Markers in Pregnant Women HIV+, With Antiretroviral Therapy, Randomized Clinical Trial.

TypeinterventionalSponsorInstituto Nacional de Perinatologia Isidro Espinosa de los ReyesRan2025 to 2029Enrolled92ConditionsPregnant HIV Positive WomenArmsomega-3 polyunsaturated fatty acids (PUFA n-3), Olive oil (placebo)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 31 citations in OpenAlex.

  1. Article
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  3. Review
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  8. Observational
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  15. Observational
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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

18 authors at 11 institutions in 3 countries.

Nava YeganehFrom the David Geffen UCLA School of Medicine, Los Angeles, California.
D Heather WattsOffice of the Global AIDS Coordinator and Health Diplomacy, US Department of State, Washington, District of Columbia.
Jiahong XuWestat, Rockville, MD.
Tara KerinFrom the David Geffen UCLA School of Medicine, Los Angeles, California.
Esau C JoaoHospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Jose Henrique PilottoHospital Geral de Nova Iguaçu, Nova Iguaçu and Laboratório de AIDS e Imunologia Molecular, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, (Fiocruz), Rio de Janeiro, Brazil.
Gerhard TheronPerinatal HIV Research Unit, Stellenbosch University/Tygerberg Hospital, Cape Town, South Africa.
Glenda GrayUniversity of Witwatersrand/Chris Hani Baragwanath Hospital, Johannesburg, South Africa.
Breno SantosHospital Conceicao, Porto Alegre, Rio Grande do Sul, Brazil.
Rosana FonsecaHospital Femina, Porto Alegre, Rio Grande do Sul, Brazil.
Regis KreitchmannIrmandade da Santa Casa de Misericordia de Porto Alegre, Rio Grande do Sul, Brazil.
Jorge PintoFederal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
Marisa M Mussi-PinhataUniversidade de Sao Paulo, Ribeirao Preto, Sao Paulo, Brazil.
Valdilea VelosoLaboratório de Pesquisa Clínica em DST e AIDS - Instituto de Pesquisa Clínica Evandro Chagas - Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.
Margaret CamarcaWestat, Rockville, MD.
Lynne MofensonElisabeth Glaser Pediatric AIDS Foundation, Washington, District of Columbia.
Jack MoyeEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Karin Nielsen-SainesFrom the David Geffen UCLA School of Medicine, Los Angeles, California.
University of California, Los Angeles · USWestat (United States) · USFundação Oswaldo Cruz · BRUnited States Department of State · USHospital Federal dos Servidores do Estado · BRHospital Nossa Senhora da Conceição · BRIrmandade da Santa Casa de Misericórdia de São Paulo · BRNational Institutes of Health · USStellenbosch University · ZAUniversidade de Ribeirão Preto · BRUniversidade Federal de Minas Gerais · BR

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
UCLA AIDS Prevention and Treatment Clinical Trials UnitU01AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 2007 to 2011
$13.9M
BRAZILIAN AIDS PREVENTION TRIALS INTERNATIONAL NETWORKU01AI047986 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI BRYSON, YVONNE J · 2000 to 2006
$13.3M
TREATMENT OF BIPOLAR DISORDERN01MH80001 · NIMH · PI WARD, SEAN · 2007 to 2007
$6.0M
TREATMENT OF BIPOLAR DISORDER-278980001N01MH080001 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · 1998 to 2003
$5.3M
TRIPAI: An innovative way to improve the health of infants by including fathers during prenatal careK23AI118584 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI YEGANEH, NAVA · 2015 to 2019
$968k
NIAID NIH HHS K23 AI118584NIAID NIH HHS U01 AI047986NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI069424NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI106716NIMH NIH HHS N01MH80001
6 · The paper itself

Abstract

backgroundHIV-exposed uninfected (HEU) infants are a growing population with potentially poor health outcomes. We evaluated morbidity and mortality in HEU formula-fed infants enrolled in the NICHD HPTN 040/PACTG 1043 trial.

methodsInfectious morbidity, mortality and undernutrition were evaluated within a cohort of 1000 HEU infants enrolled between April 2004 and April 2010 in Brazil (n = 766) and South Africa (n = 234) as part of the NICHD/HPTN 040 trial of 3 different antiretroviral regimens to decrease intrapartum HIV vertical transmission.

resultsTwenty-three percent of infants had at least 1 infectious serious adverse effect. Infants born to mothers with <12 years of education [adjusted odds ratio (AOR), 2.6; 95% confidence interval [CI], 1.2-5.9), with maternal viral load of >1,000,000 copies/mL at delivery (AOR, 9.9; 95% CI, 1.6-63.1) were more likely to have infectious serious adverse effects. At 6 months, the infant mortality rate per 1000 live births overall was 22 ± 2.6, 9.1 ± 1.8 in Brazil and 64.1 ± 3 in South Africa. Undernutrition and stunting peaked at 1 month of age with 18% having a weight-for-age Z score ≤-2, and 22% with height for Z score ≤-2. The likelihood of infant mortality was greater among infants born in South Africa compared with Brazil (AOR, 6.2; 95% CI, 2.5-15.8), high maternal viral load (AOR, 1.7; 95% CI, 1.01-2.9) and birth weight-for-age Z score ≤-2 (AOR, 5.2; 95% CI, 1.8-14.8).

conclusionsThere were high rates of undernutrition, stunting and infectious serious adverse effect in this study's formula-fed HEU population. Suppressing maternal HIV viral load during the peripartum period may be a modifiable risk factor to decrease infant mortality.

Indexed as

Infant MortalityAnti-HIV AgentsBrazilCause of DeathFemaleFollow-Up StudiesHIV InfectionsHumansInfantInfant FormulaInfectious Disease Transmission, VerticalMaleMalnutritionNutritional StatusPregnancyPregnancy Complications, InfectiousAnti-HIV Agents

Identifiers

PMID29750766
PMCPMC6226320
OpenAlexW2801247338

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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.