Clinical trial NCT05270915: End of Life Care in Neonatal Intensive Unite
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: neonatal death
end-of-life care
infants
parents
neonatal intensive care
family-centered care
Lead sponsor: Hunan Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-08
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression reported by parents.
timeFrame: Survey completed by both parents one week after discharge.
measure: satisfaction rate
timeFrame: Survey completed by both parents one week after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
Study officials:
References:
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citation: Zhang R, Tang Q, Zhu LH, Peng XM, Zhang N, Xiong YE, Chen MH, Chen KL, Luo D, Li X, Latour JM. 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. Front Pediatr. 2022 Jul 22;10:870382. doi: 10.3389/fped.2022.870382. eCollection 2022.