Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
School of Nursing and Midwifery, Edith Cowan University, Joondalup, Western Australia, Australia.
BMJ Open. 2020 Dec 4;10(12):e040991. doi: 10.1136/bmjopen-2020-040991.
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.
A descriptive study.
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.
Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation.
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'.
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.
NCT03004677.
在新生儿重症监护中进行随机对照试验（RCT）在很多方面都具有挑战性。虽然严格的纳入标准或繁忙的研究方案是明显的障碍，但很少讨论导致研究终止的外部障碍。本研究的目的是描述在一项旨在评估早产儿父母持续皮肤接触对情绪和睡眠质量的影响的 RCT 中，将家庭纳入新生儿重症监护的障碍，以及在出院时父母-婴儿互动的质量和唾液皮质醇浓度。
描述性研究。
瑞典的三个三级新生儿重症监护病房中的三个参与了一项双臂 RCT，由于纳入率低而终止。
在研究终止之前，对 242 个符合条件的家庭进行评估，其中 11 个家庭被纳入参与。
这项 RCT 的主要纳入障碍是外部的，原因是（1）新生儿病房的重症监护床位不足，导致病情稳定的婴儿比预期更快地转回转诊医院，（2）直接从产房转移到家庭病房，而不是经过开放的重症监护室，或者（3）从一个新生儿病房转移到另一个同样护理水平的病房，以增加需要时的重症监护床位。其他障碍是纳入标准“单胎”和“讲瑞典语的父母”。
纳入参与者的主要障碍是由于缺乏重症监护床位而导致新生儿病房和城市之间的转移所构成的外部障碍。这是一个与组织结构有关的多因素问题。然而，由于这会影响到进行研究的可能性，因此本研究强调了在新生儿环境中规划前瞻性干预研究时需要考虑的一些建议。
NCT03004677。
