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End of Life Care in Neonatal Intensive Unite

H

Hunan Children's Hospital

Status

Completed

Conditions

Palliative Care

Treatments

Behavioral: Family supportive care in EOLC

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

1 hour to 3 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infants whose treatment was withdrawn at Corrected Gestational Age (CGA) less than 28 days and their parents.

Exclusion criteria

  • Infants with an expected time of death less than three hours after NICU admission. Parents were excluded if they had mental health or language issues that might limit their integration and communication with the healthcare team.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Family supportive EOLC
Experimental group
Description:
The intervention 'family supportive EOLC' was developed based on the international guidelines of family-centered care (25) with additional aspects of care and support. 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.
Treatment:
Behavioral: Family supportive care in EOLC
The standard EOLC
Active Comparator group
Description:
The standard EOLC included the international guidance of palliative care and EOLC in neonatology (21-23). In China, parents are often the decision-makers of their infant's treatment and the NICU clinicians usually respect the parent's decision (24). After parents have decided to withdraw treatment, standard EOLC is initiated and includes monitoring of vital signs and withholding or withdrawing rescue procedures such as intubation and intravenous infusion. Unnecessary lines are removed and pain management is provided by analgesia. Comfort care is provided by nurses including basic care such as skin care and oral care. After the infant died, the NICU physician informs the parents by phone.
Treatment:
Behavioral: Family supportive care in EOLC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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