Evidence map›Paper›PMID 27220987›Full record

Trial reportReproductive health2016

The Antenatal Corticosteroids Trial (ACT)'s explanations for neonatal mortality - a secondary analysis.

Fernando Althabe, Vanessa Thorsten, Karen Klein, Elizabeth M McClure, Patricia L Hibberd, Robert L Goldenberg, Waldemar A Carlo, Ana Garces, Archana Patel, Omrana Pasha and 13 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Reproductive health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Antenatal Steroid Utilization in Ethiopia.Global pediatric health · 2021
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Low-dose betamethasone-acetate for fetal lung maturation in preterm sheep.American journal of obstetrics and gynecology · 2018
    Article
  14. Corticosteroids for preterm deliveries: missing evidence.The Cochrane database of systematic reviews · 2017
    Article
  15. Article
  16. Article
  17. Review
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

23 authors at 17 institutions in 7 countries.

Fernando AlthabeInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina. falthabe@iecs.org.ar.
Vanessa ThorstenRTI International, Durham, NC, USA.
Karen KleinInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.
Elizabeth M McClureRTI International, Durham, NC, USA.
Patricia L HibberdMassachusetts General Hospital, Boston, MA, USA.
Robert L GoldenbergDepartment of Obstetrics and Gynecology, Columbia University, New York, NY, USA.
Waldemar A CarloUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Ana GarcesFundación para la Alimentación y Nutrición de Centro América y Panamá, Guatemala City, Guatemala.
Archana PatelLata Medical Research Foundation, Indira Gandhi Government Medical College, Nagpur, India.
Omrana PashaDepartment of Community Health Sciences, Aga Khan University, Karachi, Pakistan.
Elwyn ChombaUniversity Teaching Hospital, Lusaka, Zambia.
Nancy F KrebsUniversity of Colorado School of Medicine, Denver, CO, USA.
Shivaprasad GoudarKLE University's Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.
Richard J DermanChristiana Health Care, Newark, DE, USA.
Fabian EsamaiMoi University School of Medicine, Eldoret, Kenya.
Edward A LiechtySchool of Medicine, Indiana University, Indianapolis, IN, USA.
Nellie I HansenRTI International, Durham, NC, USA.
Sreelatha MelethRTI International, Durham, NC, USA.
Dennis D WallaceRTI International, Durham, NC, USA.
Marion Koso-ThomasEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
Alan H JobeCincinnati Children's Hospital, Cincinnati, OH, USA.
Pierre M BuekensTulane School of Public Health & Tropical Medicine, New Orleans, LA, USA.
José M BelizánInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.
RTI International · USInstituto de Efectividad Clínica y Sanitaria · ARAga Khan University · PKChristiana Care Health System · USCincinnati Children's Hospital Medical Center · USColumbia University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USIndiana University – Purdue University Indianapolis · USInstitute of Nutrition of Central America and Panama · GTKLE University · INLata Medical Research Foundation · INMassachusetts General Hospital · USMoi University · KETulane University · USUniversity of Alabama at Birmingham · USUniversity of Colorado Denver · USUniversity Teaching Hospital · ZM

Funding

Zika in Pregnancy Supplemental Funding requestU01HD040636 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MCCLURE, ELIZABETH M · 2001 to 2017
$37.5M
UAB/AKU Global Network Research UnitU01HD040607 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GOLDENBERG, ROBERT L · 2001 to 2012
$8.5M
Complementary feeding: a Global Network cluster randomized controlled trialU01HD040657 · NICHD · UNIVERSITY OF COLORADO DENVER · PI HAMBIDGE, K MICHAEL · 2001 to 2012
$8.1M
UMKC-JNMC Global Network for Women's and Children's Health Research UnitU01HD042372 · NICHD · UNIVERSITY OF MISSOURI KANSAS CITY · PI DERMAN, RICHARD J · 2001 to 2012
$6.9M
Neonatal Resuscitation in Developing CountriesU01HD043464 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CARLO FONT, WALDEMAR A. · 2003 to 2012
$6.6M
Evidence-Based Global Health Interventions for Mothers and Children, ArgentinaU01HD040477 · NICHD · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · PI BUEKENS, PIERRE · 2001 to 2013
$5.6M
Boston University/Lata Medical Research Foundation Global Network for Women's Children's Health Research UnitUG1HD078439 · NICHD · BOSTON UNIVERSITY MEDICAL CAMPUS · PI Patricia L Hibberd · 2018 to 2026
$5.5M
Nutrition-specific interventions to improve long-term maternal-child health outcomesUG1HD076474 · NICHD · UNIVERSITY OF COLORADO DENVER · PI Edwin Jose Asturias, NANCY F KREBS · 2018 to 2026
$5.4M
The Global Network and Preconception Maternal NutritionU10HD076474 · NICHD · UNIVERSITY OF COLORADO DENVER · PI HAMBIDGE, K MICHAEL, KREBS, NANCY F · 2013 to 2017
$5.1M
Global Network for Women's and Children's Health ResearchU10HD076461 · NICHD · INDIANA UNIVERSITY INDIANAPOLIS · PI LIECHTY, EDWARD A. · 2013 to 2017
$4.1M
Improving Quality of Care for the Treatment of Childhood PneumoniaU01HD058322 · NICHD · TUFTS UNIVERSITY BOSTON · PI HIBBERD, PATRICIA L · 2008 to 2012
$4.0M
CCHS-JNMC Global Network for Women's & Children's Health Research UnitU10HD076457 · NICHD · THOMAS JEFFERSON UNIVERSITY · PI DERMAN, RICHARD J · 2013 to 2017
$3.7M
NCCIH NIH HHS K24 AT003683NICHD NIH HHS U01 HD040477NICHD NIH HHS U01 HD040607NICHD NIH HHS U01 HD040636NICHD NIH HHS U01 HD040657NICHD NIH HHS U01 HD042372NICHD NIH HHS U01 HD043464NICHD NIH HHS U01 HD058322NICHD NIH HHS U01 HD058326NICHD NIH HHS U10 HD076457NICHD NIH HHS U10 HD076461NICHD NIH HHS U10 HD076474NICHD NIH HHS U10 HD078437NICHD NIH HHS U10 HD078438NICHD NIH HHS U10 HD078439NICHD NIH HHS UG1 HD076461NICHD NIH HHS UG1 HD076474NICHD NIH HHS UG1 HD078439
6 · The paper itself

Abstract

backgroundThe Antenatal Corticosteroid Trial assessed the feasibility, effectiveness, and safety of a multifaceted intervention to increase the use of antenatal corticosteroids (ACS) in mothers at risk of preterm birth at all levels of care in low and middle-income countries. The intervention effectively increased the use of ACS but was associated with an overall increase in neonatal deaths. We aimed to explore plausible pathways through which this intervention increased neonatal mortality.

methodsWe conducted a series of secondary analyses to assess whether ACS or other components of the multifaceted intervention that might have affected the quality of care contributed to the increased mortality observed: 1) we compared the proportion of neonatal deaths receiving ACS between the intervention and control groups; 2) we compared the antenatal and delivery care process in all births between groups; 3) we compared the rates of possible severe bacterial infection between groups; and 4) we compared the frequency of factors related to ACS administration or maternal high risk conditions at administration between the babies who died and those who survived 28 days among all births in the intervention group identified as high risk for preterm birth and received ACS.

resultsThe ACS exposure among the infants who died up to 28 days was 29 % in the intervention group compared to 6 % in controls. No substantial differences were observed in antenatal and delivery care process between groups. The risk of pSBI plus neonatal death was significantly increased in intervention clusters compared to controls (2.4 % vs. 2.0 %, adjusted RR 1.17, 95 % CI 1.04-1.30, p = 0.008], primarily for infants with birth weight at or above the 25(th) percentile. Regarding factors related to ACS administration, term infants who died were more likely to have mothers who received ACS within 7 days of delivery compared to those who survived 28 days (26.5 % vs 17.9 %, p = 0.014), and their mothers were more likely to have been identified as high risk for hypertension and less likely for signs of preterm labor.

conclusionsThese results suggest that ACS more than other components of the intervention may have contributed to the overall increased neonatal mortality. ACS may have also been involved in the observed increased risk of neonatal infection and death. Further trials are urgently needed to clarify the effectiveness and safety of ACS on neonatal health in low resource settings.

Indexed as

Developing CountriesFeasibility StudiesFemaleGlucocorticoidsHumansInfantInfant MortalityInfant, NewbornPerinatal DeathPregnancyPremature BirthPrenatal CareRisk FactorsGlucocorticoids

Identifiers

PMID27220987
PMCPMC4878056
OpenAlexW2398407702

What OpenQuestion holds

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LicenceCC BY
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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.