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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.

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.

SUBMITTER: Morelius E

PROVIDER: S-EPMC7722364 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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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.

Mörelius Evalotte E Olsson Emma E Sahlén Helmer Charlotte C Thernström Blomqvist Ylva Y Angelhoff Charlotte C

BMJ open 20201204 12

<h4>Objectives</h4>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 prete ...[more]

PMID: 33277288

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Project description:BACKGROUND:Extremely premature infants (those born before 28?weeks' gestational age) are highly immature, requiring months of care at a neonatal intensive care unit (NICU). For parents, their child's grave medical condition and prolonged hospitalization are stressful and psychologically disruptive. This study aimed at exploring the needs of psychosocial support of parents of extremely premature infants, and how the NICU as an organization and its staff meets or fails to meet these needs. METHOD:Sixteen open-ended interviews were conducted with 27 parents after their infant's discharge from the NICU. Inductive content analysis was performed. RESULTS:Four themes were identified: Emotional support (with subthemes Empathic treatment by staff, Other parents as a unique source of support, Unclear roles of the various professions); Feeling able to trust the health care provider; Support in balancing time spent with the infant and other responsibilities; Privacy. Parents of extremely premature infants needed various forms of emotional support at the NICU, including support from staff, professional psychological help and/or companionship with other patients' parents. Parents were highly variable in their desire to discuss their emotional state with staff. The respective roles of nursing staff, social workers and psychologists in supporting parents emotionally and identifying particularly vulnerable parents appeared unclear. Parents also needed to be able to maintain a solid sense of trust in the NICU and its staff. Poor communication with and among staff, partly due to staff discontinuity, damaged trust. Parents struggled with perceived pressure from staff to be at the hospital more than they could manage and with the limited privacy of the NICU. CONCLUSIONS:The complex and individual psychosocial needs of parents of extremely preterm infants present many challenges for the NICU and its staff. Increasing staffing and improving nurses' competence in addressing psychosocial aspects of neonatal care would help both nurses and families. Clarifying the roles of different professions in supporting parents and developing their teamwork would lessen the burden on nurses. Communicating with parents about their needs and informing them early in their NICU stay about available support would be essential in helping them cope with their infant's hospitalization.

Project description:ImportanceThe Chinese Neonatal Network was established in 2018 and maintains a standardized national clinical database of very preterm or very low-birth-weight infants in tertiary neonatal intensive care units (NICUs) throughout China. National-level data on outcomes and care practices of very preterm infants (VPIs) in China are lacking.ObjectiveTo assess the care practices in NICUs and outcomes among VPIs in China.Design, setting, and participantsA cohort study was conducted comprising 57 tertiary hospitals from 25 provinces throughout China. All infants with gestational age (GA) less than 32 weeks who were admitted to the 57 NICUs between January 1 and December 31, 2019, were included.Main outcomes and measuresCare practices, morbidities, and survival were the primary outcomes of the study. Major morbidities included bronchopulmonary dysplasia, severe intraventricular hemorrhage (grade ≥3) and/or periventricular leukomalacia, necrotizing enterocolitis (stage ≥2), sepsis, and severe retinopathy of prematurity (stage ≥3).ResultsA total of 9552 VPIs were included, with mean (SD) GA of 29.5 (1.7) weeks and mean (SD) birth weight of 1321 (321) g; 5404 infants (56.6%) were male. Antenatal corticosteroids were used in 75.6% (6505 of 8601) of VPIs, and 54.8% (5211 of 9503)were born through cesarean delivery. In the delivery room, 12.1% of VPIs received continuous positive airway pressure and 26.7% (2378 or 8923) were intubated. Surfactant was prescribed for 52.7% of the infants, and postnatal dexamethasone was prescribed to 9.5% (636 of 6675) of the infants. A total of 85.5% (8171) of the infants received complete care, and 14.5% (1381) were discharged against medical advice. The incidences of the major morbidities were bronchopulmonary dysplasia, 29.2% (2379 of 8148); severe intraventricular hemorrhage and/or periventricular leukomalacia, 10.4% (745 of 7189); necrotizing enterocolitis, 4.9% (403 of 8171 ); sepsis, 9.4% (764 of 8171); and severe retinopathy of prematurity, 4.3% (296 of 6851) among infants who received complete care. Among VPIs with complete care, 95.4% (7792 of 8171) survived: 65.6% (155 of 236) at 25 weeks' or less GA, 89.0% (880 of 988) at 26 to 27 weeks' GA, 94.9% (2635 of 2755)at 28 to 29 weeks' GA, and 98.3% (4122 of 4192) at 30 to 31 weeks' GA. Only 57.2% (4677 of 8171) of infants survived without major morbidity: 10.5% (25 of 236) at 25 weeks' or less GA, 26.8% (48 of 179) at 26 to 27 weeks' GA, 51.1% (1409 of 2755) at 28 to 29 weeks' GA, and 69.3% (2904 of 4192) at 30 to 31 weeks' GA. Among all infants admitted, the survival rate was 87.6% (8370 of 9552)and survival without major morbidities was 51.8% (4947 of 9552).Conclusions and relevanceThe findings of this study suggest that survival and survival without major morbidity of VPIs in Chinese NICUs have improved but remain lower than in high-income countries. Comprehensive and targeted quality improvement efforts are needed to provide complete care for all VPIs, optimize obstetrical and neonatal care practices, and improve outcomes.

Dataset Information

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

Publications

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

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