Back to resultsEnd of Life Care in Neonatal Intensive Unite
Primary Purpose
Palliative Care
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Family supportive care in EOLC
Sponsored by
About this trial
This is an interventional health services research trial for Palliative Care focused on measuring neonatal death, end-of-life care, infants, parents, neonatal intensive care, family-centered care
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- Infants whose treatment was withdrawn at Corrected Gestational Age (CGA) less than 28 days and their parents.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.
Sites / Locations
- Hunan Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Family supportive EOLC
The standard EOLC
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05270915
First Posted
February 15, 2022
Last Updated
February 25, 2022
Sponsor
Hunan Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05270915
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care
Keywords
neonatal death, end-of-life care, infants, parents, neonatal intensive care, family-centered care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family supportive EOLC
Arm Type
Experimental
Arm 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.
Arm Title
The standard EOLC
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Family supportive care in EOLC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression reported by parents.
Description
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.
Time Frame
Survey completed by both parents one week after discharge.
Title
satisfaction rate
Description
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
Time Frame
Survey completed by both parents one week after discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Links:
URL
https://apps.who.int/iris/bitstream/handle/10665/342703/9789240027053-eng.pdf
Description
World Health Organization. World Health Statistics 2021. Monitoring health for the SDGs.
URL
https://www.who.int/news-room/fact-sheets/detail/palliative-care
Description
World Health Organization. Palliative Care. Key Facts.
URL
http://www.nice.org.uk/guidance/ng61
Description
National Institute for Health and Care Excellent (NICE). End of life care for infants, children and young people with life-limiting conditions: planning and management. NICE guideline
Learn more about this trial
End of Life Care in Neonatal Intensive Unite
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