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External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study
Linköping Univ, Dept Hlth Med & Caring Sci, Linköping, Sweden.;Edith Cowan Univ, Sch Nursing & Midwifery, Joondalup, WA, Australia..ORCID iD: 0000-0002-3256-5407
Örebro Univ, Sch Hlth Sci, Örebro, Sweden.;Univ Hosp Örebro, Dept Pediat, Örebro, Sweden..
Linköping Univ, Dept Hlth Med & Caring Sci, Linköping, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Perinatal, Neonatal and Pediatric Cardiology Research.ORCID iD: 0000-0001-5955-1278
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2020 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 10, no 12, article id e040991Article in journal (Refereed) Published
Abstract [en]

Objectives: Performing randomised controlled trials (RCTs) in neonatal intensive care is challenging in many ways. While restrictive inclusion criteria or busy study protocols are obvious barriers, external barriers leading to termination of a study are seldom discussed. The aim of this study was to describe barriers for inclusion of families in neonatal intensive care in an RCT aiming to evaluate the effects of continuous skin-to-skin contact on mood and sleep quality in parents of preterm infants, as well as the quality of parent-infant interaction and salivary cortisol concentrations at the time of discharge.

Design: A descriptive study.

Setting: Three out of seven tertiary neonatal intensive care units in Sweden participated in a two-arm RCT that was terminated because of low inclusion rate.

Participants: Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation. Results The major barriers for inclusion in this RCT were external due to (1) lack of intensive care beds in the neonatal ward, causing medically stable infants to be transferred back to the referring hospital quicker than expected, (2) moving directly from the delivery room to a family room without passing an open bay intensive care room or (3) transferring from one neonatal ward to another with the same care level to increase availability of intensive care beds where needed. Other barriers were the inclusion criteria 'single-birth' and 'Swedish-speaking parent'.

Conclusions: The major barriers for including participants were external constituted by transferals between neonatal wards and cities due to lack of intensive care beds. This is a multifactorial issue related to organisational structures. However, since this affects the possibilities to perform research this study highlights some suggestions to consider when planning prospective intervention studies within a neonatal setting.

Place, publisher, year, edition, pages
BMJ PUBLISHING GROUP , 2020. Vol. 10, no 12, article id e040991
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Nursing Pediatrics
Identifiers
URN: urn:nbn:se:uu:diva-431847DOI: 10.1136/bmjopen-2020-040991ISI: 000600203000018PubMedID: 33277288OAI: oai:DiVA.org:uu-431847DiVA, id: diva2:1519154
Funder
Medical Research Council of Southeast Sweden (FORSS), FORSS -661721Available from: 2021-01-18 Created: 2021-01-18 Last updated: 2023-08-28Bibliographically approved

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Thernström Blomqvist, Ylva

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