External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study

Evalotte Mörelius; Emma Olsson; Charlotte Sahlén Helmer; Ylva Thernström Blomqvist; Charlotte Angelhoff

doi:10.1136/bmjopen-2020-040991

External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study

BMJ Open. 2020 Dec 4;10(12):e040991. doi: 10.1136/bmjopen-2020-040991.

Authors

Evalotte Mörelius^{1

2}, Emma Olsson^{3

4}, Charlotte Sahlén Helmer⁵, Ylva Thernström Blomqvist^{6

7}, Charlotte Angelhoff⁸

Affiliations

¹ Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden evalotte.morelius@liu.se.
² School of Nursing and Midwifery, Edith Cowan University, Joondalup, Western Australia, Australia.
³ School of Health Sciences, Örebro University, Örebro, Sweden.
⁴ Department of Pediatrics, University Hospital Örebro, Örebro, Sweden.
⁵ Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
⁶ Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
⁷ Neonatal Intensive Care Unit, Uppsala University Hospital, Uppsala, Sweden.
⁸ Crown Princess Victoria's Child and Youth Hospital and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.

Abstract

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.

Trial registration number: NCT03004677.

Keywords: Clinical trials; neonatal intensive & critical care; neonatology; statistics & research methods.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Infant
Infant, Newborn
Infant, Premature*
Intensive Care Units, Neonatal*
Parents
Prospective Studies
Sweden

Associated data

ClinicalTrials.gov/NCT03004677