ArticleArchives of disease in childhood. Fetal and neonatal edition2003
Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study.
Article in Archives of disease in childhood. Fetal and neonatal edition, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 44 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.PloS one · 2024Pooled it
- Pooled it
- Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis.Bulletin of the World Health Organization · 2015Pooled it
- Trial
- Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences.Archives of disease in childhood. Fetal and neonatal edition · 2021Trial
- Two speeds of increasing milk feeds for very preterm or very low-birthweight infants: the SIFT RCT.Health technology assessment (Winchester, England) · 2020Trial
- Trial
- Trial
- Parental involvement in neonatal decision-making: a narrative review.Frontiers in pediatrics · 2026Review
- Motivations for and against Participation in Neonatal Research: Insights from Interviews of Diverse Parents Approached for Neonatal Research in the United States.The Journal of pediatrics · 2024Article
- Parental perspectives on a trial using waived informed consent at birth.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- Are we enrolling representative cohorts of premature infants in our clinical trials?Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Parental Enrollment Decision-Making for a Neonatal Clinical Trial.The Journal of pediatrics · 2021Article
- The culture of research communication in neonatal intensive care units: key stakeholder perspectives.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Deferred Consent in Neonatal Clinical Research: Why, When, How?Paediatric drugs · 2021Review
- Parental Attitudes toward Consent for Music Intervention Studies in Preterm Infants: A Cross-Sectional Study.International journal of environmental research and public health · 2021Article
- Tiny Bodies, Big Needs: Prospective Biobanking of Neonatal Clinical Remnant Samples.Biopreservation and biobanking · 2021Article
- Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.JAMA network open · 2021Article
- Lay persons' perception of the requirements for research in emergency obstetric and newborn care.BMC medical ethics · 2021Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecruitment into research studies in the neonatal intensive care unit has been problematic. Therefore suggestions have been made to take decision making about enrollment out of the hands of the parents.
objectiveTo understand parental perceptions of the process of recruitment and enrollment for research in the neonatal intensive care unit.
methodA questionnaire was developed and used in both a retrospective survey and a prospective study of parents whose newborns were enrolled in trials in a neonatal intensive care unit. Closed ended and open ended questions were included, as well as demographic questions.
resultsThe retrospective survey had a 79% response rate (29 of 38). Overall, 90% of parents felt that they had made informed decisions, and 93% were against the option that a doctor decide if the newborn should be enrolled into a study, rather than the parent. Although some parents (38%) found that recruitment did add "stress to an already stressful situation", 90% felt that they had made informed decisions and understood the elements of the study. Most parents had been requested to enroll their newborn into more than one trial, and, on average, they thought that they would be comfortable with enrollment into two studies (range 0-6). When asked how the process could be improved, parents suggested that information be made available before delivery. The responses of parents in the prospective study were mostly consistent with those from the retrospective survey.
conclusionsOverall the parents did not support the suggestion that decision making about enrollment be taken away from parents and put into the hands of doctors. The healthcare team should support parents in their role of decision maker, enhance availability of the research staff, and provide more information about the research.
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What OpenQuestion holds
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.