Evidence map›Paper›PMID 30380581›Full record

SynthesisAmerican journal of perinatology2019

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials.

I Blaire Hanvey, Sofia Aliaga, Matthew M Laughon, Daniela Testoni, P Brian Smith, Melissa Bauserman

Abstract readComparative StudySystematic Review
In one paragraph

Synthesis in American journal of perinatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

6 authors.

I Blaire HanveyDepartment of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Sofia AliagaDepartment of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Matthew M LaughonDepartment of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Daniela TestoniEscola Paulista de Medicina-Universidade Federal de São Paulo, Brazil.
P Brian SmithDepartment of Pediatrics, Duke University Medical Center, Durham, North Carolina.
Melissa BausermanDepartment of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

Funding

Mentorship of Early-Career Clinicians in Bronchopulmonary Dysplasia Drug TherapiesK24HL143283 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2019 to 2023
$613k
NHLBI NIH HHS K24 HL143283
6 · The paper itself

Abstract

objectiveThe main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates. STUDY

designWe included neonatal drug trials published between 2009 and 2014 and compared parental consent rates among the following characteristics: phase type, gestational age, randomization type, drug administration route, drug dosing frequency, blood sampling, control type, length of study, funding source, and length of treatment. We compared characteristics using chi-square, Fisher's exact, one-way analysis of variance or Kruskal-Wallis tests.

resultsWe identified 52 trials: 38 trials (73%) reported data of parental consent. Median percentage (interquartile range) of parental consent was 79% (62, 89). Higher rates were observed in studies that used active comparators (87%) and shorter study lengths (81% for studies <24 hours).

conclusionParental consent rates for neonatal drug trials varied by study characteristics. Information on proportion of parents consented is valuable to assess generalizability of trial results and for preparing trial protocols.

Indexed as

Clinical Trials as TopicDrug TherapyAttitude to HealthDrug EvaluationHumansInfant, NewbornParental ConsentParents

Identifiers

PMID30380581
PMCPMC8565499

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.