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Completed

NCT Number: NCT05270915

End of Life Care in Neonatal Intensive Unite

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.

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Key information

Conditions

Palliative Care Death Female Urogenital Diseases and Pregnancy Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Age range

1 hour–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunan Children's Hospital

Changsha, Hunan, 410007, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family supportive care in EOLC

Behavioral

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 outcomes

  1. Depression reported by parents.

    Time frame: Survey completed by both parents one week after discharge.

    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.

  2. satisfaction rate

    Time frame: Survey completed by both parents one week after discharge.

    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

Sponsors and collaborators

Lead sponsor

Hunan Children's Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2022
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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