- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hunan
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Changsha, Hunan, China, 410007
- Hunan Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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- Infants whose treatment was withdrawn at Corrected Gestational Age (CGA) less than 28 days and their parents.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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Family supportive EOLC
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 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.
|
ACTIVE_COMPARATOR: The standard EOLC
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression reported by parents.
Time Frame: Survey completed by both parents one week after discharge.
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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.
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satisfaction rate
Time Frame: Survey completed by both parents one week after discharge.
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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
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Survey completed by both parents one week after discharge.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Silverman WA. A hospice setting for humane neonatal death. Pediatrics. 1982 Feb;69(2):239. No abstract available.
- Kim S, Savage TA, Hershberger PE, Kavanaugh K. End-of-Life Care in Neonatal Intensive Care Units from an Asian Perspective: An Integrative Review of the Research Literature. J Palliat Med. 2019 Jul;22(7):848-857. doi: 10.1089/jpm.2018.0304. Epub 2019 Jan 11.
- Haug S, Dye A, Durrani S. End-of-Life Care for Neonates: Assessing and Addressing Pain and Distressing Symptoms. Front Pediatr. 2020 Sep 24;8:574180. doi: 10.3389/fped.2020.574180. eCollection 2020.
- Dombrecht L, Beernaert K, Chambaere K, Cools F, Goossens L, Naulaers G, Cohen J, Deliens L; NICU consortium. End-of-life decisions in neonates and infants: a population-level mortality follow-back study. Arch Dis Child Fetal Neonatal Ed. 2022 May;107(3):340-341. doi: 10.1136/archdischild-2021-322108. Epub 2021 Jun 15. No abstract available.
- Veldhuijzen van Zanten S, Ferretti E, MacLean G, Daboval T, Lauzon L, Reuvers E, Vadeboncoeur C. Medications to manage infant pain, distress and end-of-life symptoms in the immediate postpartum period. Expert Opin Pharmacother. 2022 Jan;23(1):43-48. doi: 10.1080/14656566.2021.1965574. Epub 2021 Aug 18.
- Allen JD, Shukla R, Baker R, Slaven JE, Moody K. Improving Neonatal Intensive Care Unit Providers' Perceptions of Palliative Care through a Weekly Case-Based Discussion. Palliat Med Rep. 2021 Apr 16;2(1):93-100. doi: 10.1089/pmr.2020.0121. eCollection 2021.
- Chen X, Li H, Song J, Sun P, Lin B, Zhao J, Yang C. The Resuscitation of Apparently Stillborn Neonates: A Peek Into the Practice in China. Front Pediatr. 2020 Jun 2;8:231. doi: 10.3389/fped.2020.00231. eCollection 2020.
- Maurer DM, Raymond TJ, Davis BN. Depression: Screening and Diagnosis. Am Fam Physician. 2018 Oct 15;98(8):508-515.
- Nixon N, Guo B, Garland A, Kaylor-Hughes C, Nixon E, Morriss R. The bi-factor structure of the 17-item Hamilton Depression Rating Scale in persistent major depression; dimensional measurement of outcome. PLoS One. 2020 Oct 26;15(10):e0241370. doi: 10.1371/journal.pone.0241370. eCollection 2020.
- Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- 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.
Helpful Links
- World Health Organization. World Health Statistics 2021. Monitoring health for the SDGs.
- World Health Organization. Palliative Care. Key Facts.
- 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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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