Evidence map›Paper›PMID 41051016›Full record

ArticleActa paediatrica (Oslo, Norway : 1992)2026

Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations.

Susanne Soendergaard Kappel, Gustav Riemer Jakobsen, Kija Lin Oestergaard, Anders Brunse, Dennis Sandris Nielsen, Lise Aunsholt

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Acta paediatrica (Oslo, Norway : 1992), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05272566 completednot on this map

Prephage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Donor Study

TypeobservationalSponsorRigshospitalet, DenmarkRan2022 to 2024Enrolled38ConditionsFeeding Patterns, Microbial Colonization
NCT05272579 early_phase1recruitingnot on this map

PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Clinical Trial

TypeinterventionalSponsorRigshospitalet, DenmarkRan2023 to 2025Enrolled20ConditionsNecrotizing Enterocolitis, Microbial SubstitutionArmsFecal Filtrate Transfer, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Susanne Soendergaard KappelDepartment of Neonatology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-2023-298X
Gustav Riemer JakobsenDepartment of Neonatology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Kija Lin OestergaardThe Research and Implementation Unit PROgrez, Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark.ORCID 0000-0001-8211-0999
Anders BrunseDepartment of Veterinary and Animal Sciences, Section for Comparative Paediatrics and Nutrition, University of Copenhagen, Copenhagen, Denmark.
Dennis Sandris NielsenDepartment of Food Science, Section for Food Microbiology, Gut Health and Fermentation, University of Copenhagen, Copenhagen, Denmark.
Lise AunsholtDepartment of Neonatology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Funding

Novo Nordisk Fonden NNF20OC0063874
6 · The paper itself

Abstract

aimRecruiting participants for neonatal clinical studies may be challenging because parental consent is required shortly after birth. This study aimed to explore reasons for parental decline of participation in a neonatal study.

methodThis qualitative sub-study was conducted in the Capital Region of Denmark between June 2022 and April 2023. Parents of healthy term newborn infants who declined participation in the PrePhage study, a study investigating the transfer of faecal filtrate for the prevention of necrotising enterocolitis, were included. These parents were interviewed through semi-structured telephone interviews. Data were analysed using thematic analysis.

resultsTen parents (five mothers and five fathers of 10 different newborn infants) participated. All were first-time parents. Three themes were identified: the first theme, uncertainty of the unknown, captured how early parenthood influenced willingness to engage. The second theme, challenges and discomfort related to sample collection, reflected logistical burdens and discomfort associated with faecal samples. The third theme, balancing societal expectations, described the tension between the social value of research and expressed guilt for declining participation.

conclusionEmotional, logistical and societal factors influenced parents' decision to decline participation in neonatal research. Future enrolment strategies should consider the timing of approach and aim to minimise participation burden.

trial registrationClinicalTrials.gov identifier: NCT05272579 and NCT05272566.

Indexed as

Parental ConsentParentsAdultClinical Trials as TopicDenmarkFemaleHumansInfant, NewbornMaleQualitative ResearchUncertaintybarriers to consentinformed consentneonatal researchparental decision‐makingrecruitment challengesthematic analysis

Identifiers

PMID41051016
PMCPMC12794787

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.