End of Life Care in Neonatal Intensive Unite

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Palliative Care

Intervention / Treatment
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* Behavioral: Family supportive care in EOLC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family supportive EOLC<br>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. | Behavioral: Family supportive care in EOLC<br>* 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.<br>|
| Active Comparator: The standard EOLC<br>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. | Behavioral: Family supportive care in EOLC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression reported by parents. | Use the Chinese version of the Hamilton Depression rating scale (HAMD) to evaluate depression among fathers. The Chinese version of the EPDS was used to assess depression among mothers. The HAMD includes 17 items with a 3 or 5-point Likert answer option scale with a total score of 78. The EPDS includes 10 items with a 4-point Likert answer option scale with a total score of 30. The higher scores means worse outcome. | Survey completed by both parents one week after discharge. | 
| satisfaction rate | Parent satisfaction was measured by the hospital standard parent satisfaction survey completed by both parents one week after discharge.The parent satisfaction instrument includes 20 items using a 5-point Likert answer option scale with a total score of 100.The higher scores means better outcomes | Survey completed by both parents one week after discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal death, end-of-life care, infants, parents, neonatal intensive care, family-centered care