Evidence map›Paper›PMID 21727276›Full record

Trial reportArchives of pediatrics & adolescent medicine2011

Effects of prophylactic indomethacin in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids.

Barbara Schmidt, Mary Seshia, Seetha Shankaran, Lindsay Mildenhall, Jon Tyson, Kei Lui, Tai Fok, Robin Roberts, Trial of Indomethacin Prophylaxis in Preterms Investigators

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of pediatrics & adolescent medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00009646 (Trial of Indomethacin Prophylaxis in Preterm Infants), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
–field-weighted citation impact, top 79% 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.

NCT00009646 phase3completednot on this map

Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

TypeinterventionalSponsorNICHD Neonatal Research NetworkRan1993 to 2001Enrolled1,202ConditionsInfant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, PatentArmsindomethacin, Indomethacin, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Impact of nonaspirin nonsteroidal anti-inflammatory agents and acetaminophen on sensorineural hearing loss: a systematic review.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2015
    Pooled it
  3. Wide variation in death rates and post-hemorrhagic hydrocephalus (PHH) treatment in preterm severe intraventricular hemorrhage (IVH).Journal of perinatology : official journal of the California Perinatal Association · 2026
    Observational
  4. Article
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  6. Review
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  12. 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

9 authors at 1 institution in 1 country.

Barbara SchmidtDepartment of Pediatrics, Hospital of the University of Pennsylvania, Ravdin 8, 3400 Spruce St, Philadelphia, PA 19104, USA. Barbara.Schmidt@uphs.upenn.edu
Mary Seshia
Seetha Shankaran
Lindsay Mildenhall
Jon Tyson
Kei Lui
Tai Fok
Robin Roberts
Trial of Indomethacin Prophylaxis in Preterms Investigators
Hospital of the University of Pennsylvania · US

Funding

XOLAIR IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH FOOD ALLERGYM01RR000070 · NCRR · STANFORD UNIVERSITY · PI RASGON, NATALIE L · 1985 to 2008
$32.4M
ZUNI KIDNEY PROJECT STUDY I--POPULATION BASED SURVEY OF RENAL DISEASEM01RR000997 · NCRR · UNIVERSITY OF NEW MEXICO · PI ROLDAN, CARLOS A · 1985 to 2010
$30.0M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021385 · NICHD · WAYNE STATE UNIVERSITY · PI SHANKARAN, SEETHA · 1991 to 2015
$8.7M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027904 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI LAPTOOK, ABBOT R · 1991 to 2015
$8.7M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD034216 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CARLO FONT, WALDEMAR A. · 1996 to 2015
$6.4M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027880 · NICHD · STANFORD UNIVERSITY · PI VAN MEURS, KRISA PAGE · 1991 to 2015
$6.1M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021373 · NICHD · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI KENNEDY, KATHLEEN A · 1991 to 2015
$6.1M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021364 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI WALSH, MICHELE · 1991 to 2015
$6.1M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027851 · NICHD · EMORY UNIVERSITY · PI CARLTON, DAVID · 1991 to 2015
$5.0M
NICHD Neonatal Research Network Clinical Center UABUG1HD034216 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WALDEMAR A. CARLO FONT · 2016 to 2026
$3.3M
NCATS NIH HHS UL1 TR000454NCRR NIH HHS M01 RR000070NCRR NIH HHS M01 RR 00070NCRR NIH HHS M01 RR000997NCRR NIH HHS M01 RR 00997NCRR NIH HHS UL1 RR025008NICHD NIH HHS U10 HD021364NICHD NIH HHS U10 HD021373NICHD NIH HHS U10 HD021385NICHD NIH HHS U10 HD027851NICHD NIH HHS U10 HD027880NICHD NIH HHS U10 HD027881NICHD NIH HHS U10 HD027904NICHD NIH HHS U10 HD034216NICHD NIH HHS U10 HD21364NICHD NIH HHS U10 HD21373NICHD NIH HHS U10 HD21385NICHD NIH HHS U10 HD27851NICHD NIH HHS U10 HD27880NICHD NIH HHS U10 HD27881NICHD NIH HHS U10 HD27904NICHD NIH HHS U10 HD34216NICHD NIH HHS UG1 HD034216
6 · The paper itself

Abstract

objectiveTo examine whether treatment with antenatal corticosteroids modifies the immediate and long-term effects of prophylactic indomethacin sodium trihydrate in extremely low-birth-weight infants.

designPost hoc subgroup analysis of data from the Trial of Indomethacin Prophylaxis in Preterms.

settingThirty-two neonatal intensive care units in Canada, the United States, Australia, New Zealand, and Hong Kong.

participantsA total of 1195 infants with birth weights of 500 to 999 g and known exposure to antenatal corticosteroids. We defined as adequate any exposure to antenatal corticosteroids that occurred at least 24 hours before delivery.

interventionIndomethacin or placebo intravenously once daily for the first 3 days. OUTCOME MEASURES: Death or survival to 18 months with cerebral palsy, cognitive delay, severe hearing loss, or bilateral blindness; severe periventricular and intraventricular hemorrhage; patent ductus arteriosus; and surgical closure of a patent ductus arteriosus.

resultsOf the 1195 infants in this analysis cohort, 670 had adequate and 525 had inadequate exposure to antenatal corticosteroids. There was little statistical evidence of heterogeneity in the effects of prophylactic indomethacin between the subgroups for any of the outcomes. The adjusted P values for interaction were as low as .15 for the outcome of death or impairment at 18 months and as high as .80 for the outcome of surgical duct closure.

conclusionWe find little evidence that the effects of prophylactic indomethacin vary in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids. Trial Registration clinicaltrials.gov Identifier: NCT00009646.

Indexed as

Infant, Extremely Low Birth WeightAdrenal Cortex HormonesAnti-Inflammatory Agents, Non-SteroidalDevelopmental DisabilitiesFemaleHumansIndomethacinInfant, NewbornInfant, Premature, DiseasesMalePrenatal CareTreatment OutcomeAdrenal Cortex HormonesAnti-Inflammatory Agents, Non-SteroidalIndomethacin

Identifiers

PMID21727276
PMCPMC3397141
OpenAlexW2158229298

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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.