End of Life Care in Neonatal Intensive Unite

Palliative Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270915
• Other study ID #: HN08
• Status: Completed
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2022
• Source: Hunan Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Palliative Care

Intervention

Behavioral:
• Family supportive care in EOLC
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.

Locations

Country	Name	City	State
China	Hunan Children's Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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 202 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. 2021 Jun 15. pii: — View Citation

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. Review. — View Citation

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. Review. — View Citation

Maurer DM, Raymond TJ, Davis BN. Depression: Screening and Diagnosis. Am Fam Physician. 2018 Oct 15;98(8):508-515. — View Citation

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 — View Citation

Silverman WA. A hospice setting for humane neonatal death. Pediatrics. 1982 Feb;69(2):239. — View Citation

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: — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.

External Links

•   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
•   World Health Organization. Palliative Care. Key Facts.
•   World Health Organization. World Health Statistics 2021. Monitoring health for the SDGs.
•   Worldwide Palliative Care Alliance and World Health Organization. Global atlas of palliative care at the end of life