ArticlePloS one2018
Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis 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
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Parental Views of Facilitators and Barriers to Research Participation: Systematic Review.Pediatrics · 2023Pooled it
- Development and Preliminary Evaluation of a Questionnaire on Parental Informed Consent in Neonatal Research.Children (Basel, Switzerland) · 2026Article
- Engaging families with experience of neonatal hypoxic ischemic encephalopathy: a call to action.Pediatric research · 2026Review
- Neonatal Thromboembolic Disease: Clinical Spectrum and Emerging Evidence for Diagnostic and Therapeutic Strategies Addressing Unmet Needs.Journal of clinical medicine · 2026Review
- Facilitators and barriers in obtaining informed consent for neonatal research: a scoping review.European journal of pediatrics · 2026Article
- Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.Contemporary clinical trials communications · 2024Article
- Parental Enrollment Decision-Making for a Neonatal Clinical Trial.The Journal of pediatrics · 2021Article
- Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.JAMA network open · 2021Article
- Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era.Frontiers in pediatrics · 2021Article
- Article
- Barriers and Challenges in Performing Pharmacokinetic Studies to Inform Dosing in the Neonatal Population.Pharmacy (Basel, Switzerland) · 2020Review
- Informed consent for neonatal trials: practical points to consider and a check list.BMJ paediatrics open · 2020Review
- The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.BMC pediatrics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesParental consent for the participation of their neonate in neonatal research is influenced by the quality of the information delivered and the interaction between parents and investigators. Failure to provide important information may lead to difficulties in the decision making process of parents. This Delphi survey aims to establish a consensus between parent representatives of neonatal associations and healthcare professionals concerning the information deemed essential by both parties in order to improve the recruitment of neonates into clinical trials.
methodThis study was conducted in Europe among parent representatives and healthcare professionals. In this 3-phase study, 96 items were defined by the Scientific Committee (CS), composed of 11 clinicians (from 8 countries) and 1 parent representative of the European network of neonatal associations. Then the Committee of Experts (CE) composed of 16 clinicians were matched by country with 16 national parent representatives and evaluated these items in two rounds. The importance of each item was evaluated by each member of the CE on a scale between 1 and 9 based on their personal experience.
resultsFifty eight items reached the second and final level of consensus. In contrast to clinicians, parent representatives preferred to be informed about the study by the physician in charge of their child. They also favoured additional support during the informed consent process and stated that both parents need to agree and sign.
conclusionThe set of 58 items on which parents and clinicians reached consensus will be helpful to healthcare professionals seeking parental consent for the inclusion of a neonate in a clinical trial. Providing parents with information about the trial by the investigator in the presence of the patient's neonatologist, developing closer contacts with parents and informing them of the available support by parents associations may be helpful for parents.
Indexed as
Identifiers
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.