NCT01926080

Brief Summary

Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn. The purpose of this study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program and the use of a newly designed family-centered bereavement DVD. This educational DVD includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the NICU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2017

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

August 16, 2013

Last Update Submit

January 6, 2025

Conditions

GriefDepressive Symptoms

Keywords

DepressionSpiritualityNeonatal deathBereavementRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Parental Grief

    To characterize and describe changes in grief at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.

    3 and 12 months following death of a newborn

Secondary Outcomes (1)

  • Depressive Mood Symptoms

    3 and 12 months following death of a newborn

Study Arms (2)

DVD Intervention Arm

OTHER

Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.

Other: DVD Intervention Arm

Standard Bereavement Care

NO INTERVENTION

Those randomized to control group (no DVD) Standard Bereavement Care Arm receive the bereavement materials given to families as standard-practice of care in the NICU at SLCH following the death of an infant

Interventions

DVD Intervention ArmOTHER

Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.

DVD Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Any parent who has experienced the death of a baby in the NICU at SLCH or has had a baby treated in the NICU who has died at home with hospice care

You may not qualify if:

  • Babies who are at home longer than one month with hospice care will be excluded
  • Those who are not English speaking or who are illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Rosenbaum JL, Smith JR, Yan Y, Abram N, Jeffe DB. Impact of a Neonatal-Bereavement-Support DVD on Parental Grief: A Randomized Controlled Trial. Death Stud. 2015 Jan-Jun;39(1-5):191-200. doi: 10.1080/07481187.2014.946628. Epub 2014 Dec 20.

    PMID: 25530502DERIVED

MeSH Terms

Conditions

DepressionPerinatal Death

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2013

First Posted

August 20, 2013

Study Start

January 1, 2008

Primary Completion

February 1, 2011

Study Completion

August 9, 2017

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

US(1)