Evidence map›Paper›PMID 35811154›Full record

Trial reportSeminars in perinatology2022

Special considerations in randomized trials investigating neonatal surgical treatments.

Martin L Blakely, Matthew A Rysavy, Kevin P Lally, Barry Eggleston, Claudia Pedroza, Jon E Tyson

Abstract readClinical Trial
In one paragraph

Trial report in Seminars in perinatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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. Trial
  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

6 authors.

Martin L BlakelyVanderbilt University Medical Center, Department of Pediatric Surgery, Nashville, TN, USA; McGovern Medical School at the University of Texas Health Science Center at Houston, Division of Neonatology, Department of Pediatrics, and Center for Clinical Research and Evidence-Based Medicine, Houston, TX, USA. Electronic address: Martin.blakely@vumc.org.
Matthew A RysavyMcGovern Medical School at the University of Texas Health Science Center at Houston, Division of Neonatology, Department of Pediatrics, and Center for Clinical Research and Evidence-Based Medicine, Houston, TX, USA.
Kevin P LallyMcGovern Medical School at the University of Texas Health Science Center at Houston, Department of Pediatric Surgery, Houston, TX, USA.
Barry EgglestonRTI International, Social, Statistical and Environmental Sciences Unit, Research Triangle Park, NC, USA.
Claudia PedrozaMcGovern Medical School at the University of Texas Health Science Center at Houston, Division of Neonatology, Department of Pediatrics, and Center for Clinical Research and Evidence-Based Medicine, Houston, TX, USA.
Jon E TysonMcGovern Medical School at the University of Texas Health Science Center at Houston, Division of Neonatology, Department of Pediatrics, and Center for Clinical Research and Evidence-Based Medicine, Houston, TX, USA.

Funding

Neonatal Research Network Data Coordinating Center (DCC)U10HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2008 to 2017
$62.3M
Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Data Ctr for the Cooperative Neonatal Research NetworkU01HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 1998 to 2007
$21.8M
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 NetworkU10HD027871 · NICHD · YALE UNIVERSITY · PI EHRENKRANZ, RICHARD A. · 1991 to 2012
$3.9M
NICHD Neonatal Research Network -- Cincinnati Clinical CenterUG1HD027853 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI STEPHANIE L MERHAR · 2016 to 2026
$3.7M
Clinical Center for NICHD/Neonatal Research NetworkUG1HD068244 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Sara Bonamo DeMauro, Eric C Eichenwald · 2016 to 2026
$3.6M
NICHD COPPERATIVE MULTICENTER NEONATAL RESEARCH NETWORKUG1HD040689 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI Myra Helen Wyckoff · 2016 to 2026
$3.5M
NICHD Neonatal Research Network Clinical Center - Case Western Reserve UniversityUG1HD021364 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI Anna Maria Hibbs · 2016 to 2026
$3.5M
North Carolina Clinical CenterUG1HD040492 · NICHD · DUKE UNIVERSITY · PI CHARLES Michael COTTEN, Matthew Laughon · 2016 to 2026
$3.4M
NICHD Cooperative Multicenter Neonatal Research Network - Utah CenterUG1HD087226 · NICHD · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI ROBIN K OHLS · 2016 to 2026
$3.3M
NICHD Neonatal Research Network - Stanford UniversityUG1HD027880 · NICHD · STANFORD UNIVERSITY · PI Valerie Chock · 2016 to 2026
$3.3M
NCATS NIH HHS UL1 TR001117NICHD NIH HHS L40 HD099827NICHD NIH HHS U01 HD036790NICHD NIH HHS U10 HD021373NICHD NIH HHS U10 HD027871NICHD NIH HHS U10 HD036790NICHD NIH HHS U10 HD053119NICHD NIH HHS UG1 HD021364NICHD NIH HHS UG1 HD021385NICHD NIH HHS UG1 HD027851NICHD NIH HHS UG1 HD027853NICHD NIH HHS UG1 HD027856NICHD NIH HHS UG1 HD027880NICHD NIH HHS UG1 HD027904NICHD NIH HHS UG1 HD034216NICHD NIH HHS UG1 HD040492NICHD NIH HHS UG1 HD040689NICHD NIH HHS UG1 HD053089NICHD NIH HHS UG1 HD053109NICHD NIH HHS UG1 HD068244NICHD NIH HHS UG1 HD068263NICHD NIH HHS UG1 HD068270NICHD NIH HHS UG1 HD068278NICHD NIH HHS UG1 HD068284NICHD NIH HHS UG1 HD087226NICHD NIH HHS UG1 HD087229
6 · The paper itself

Abstract

Randomized controlled trials (RCTs) are challenging, but are the studies most likely to change practice and benefit patients. RCTs investigating neonatal surgical therapies are rare. The Necrotizing Enterocolitis Surgery Trial (NEST) was the first surgical RCT conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN), and multiple lessons were learned. NEST was conducted over a 7.25-year enrollment period and the primary outcome was death or neurodevelopmental impairment (NDI) at 18-22 months corrected age. Surgical investigators designing clinical trials involving neonatal surgical treatments have many considerations to include, including how to study eligible but non-randomized patients, heterogeneity of treatment effect, use of frequentist and Bayesian analyses, assessment of generalizability, and anticipating criticisms during peer review. Surgeons are encouraged to embrace these challenges and seek innovative methods to acquire evidence that will be used to improve patient outcomes.

Indexed as

Enterocolitis, NecrotizingInfant, Newborn, DiseasesChildHumansInfant, NewbornNational Institute of Child Health and Human Development (U.S.)Randomized Controlled Trials as TopicUnited States

Identifiers

PMID35811154
PMCPMC9529875

What OpenQuestion holds

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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.