NCT05270915

End of Life Care in Neonatal Intensive Unite

Testing a Family Supportive End of Life Care Intervention in a Chinese Neonatal Intensive Care Unit: A Quasi-experimental Study With a Non-randomized Controlled Trial Design

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hunan Children's Hospital · Other Government
• Sex: All
• Age: 1 Hour – 3 Months
• Healthy volunteers: Not accepted

Summary

In China, neonatal death on 2019 was 3.5 per 1000 live births, which counts around 57,000 deaths. In mainland China, parents are mostly the main decision-makers in withdrawing life-sustaining treatments in infants and neonatologists often follow the wishes of the parents. However, there is limited experience in supporting parents after the decision is made to withdraw treatment. The aim of this study was to develop and test a family supportive end-of-life care intervention to decrease parental depression and increase parent satisfaction. Investigators indicated that providing a comfortable environment and supportive care to parents during the final days of life of an infant decrease their depression and increases parent satisfaction. The NICUs in mainland China and beyond might consider involving parents in end-of-life care by providing a single room, have a dedicated psychologist available and provide supportive commemoration materials.

Detailed description

Neonatal death often occurs in tertiary Neonatal Intensive Care Units (NICUs). In China, end-of-life-care (EOLC) does not always involve parents. The aim of this study is to evaluate a parent support intervention to integrate parents at the end of life of their infant in the NICU. A quasi-experimental study using a non-randomized clinical trial design was conducted between May 2020 and September 2021. Participants were infants in an EOLC pathway in the NICU and their parents. Parents were allocated into a family supportive EOLC intervention group or a standard EOLC group based on their wishes. Primary outcomes were depression (Edinburgh Postnatal Depression Scale for mothers; Hamilton Depression rating scale for fathers) and satisfaction. Student t-test for continuous variables and the Chi-square test categorical variables were used in the statistical analysis.

Conditions

• Palliative Care

Interventions

Type	Name	Description
BEHAVIORAL	Family supportive care in EOLC	The investigators designed a separated single-bedded EOLC room for the infant and parents. Other family members, such as grandparents or siblings, were allowed to visit the infant and parents. The design of the room included the option for parents to stay comfortably on a sofa to relax and to play soothing music. Parents were encouraged to stay as long as they want and participate in basic care including physical contact with their infant. The nurses supported the parents in creating commemorative items such as a 'Yuan man' box with photos, baby handprint cards, footprint cards, a lock of hair and other precious memory items. A psychologist, in collaboration with our NICU, and a neonatologist supported the parents by individual interviews.

Timeline

• Start date: 2020-05-06
• Primary completion: 2021-09-20
• Completion: 2021-09-30
• First posted: 2022-03-08
• Last updated: 2022-03-08

Locations

1 site across 1 country: China