AI Article Synopsis
- Performing randomized controlled trials (RCTs) in neonatal intensive care is challenging, and this study aimed to identify external barriers hindering family inclusion in a specific RCT evaluating continuous skin-to-skin contact for parents of preterm infants.
- The study was conducted in three out of seven tertiary neonatal intensive care units in Sweden, but was terminated due to a low inclusion rate, with only 11 out of 242 eligible families participating.
- Key barriers included a shortage of intensive care beds leading to quick transfers of medically stable infants, direct movement from delivery rooms to family rooms, and strict eligibility criteria such as requiring single-birth infants and Swedish-speaking parents.
Article 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.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722364 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2020-040991 | DOI Listing |
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