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

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of eligibility, barriers for inclusion and included families.

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