Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room
PALLI-ACC
1 other identifier
observational
100
1 country
4
Brief Summary
The newborn feels pain and the newborn at the end of life, in the delivery room, is potentially exposed to pain and respiratory distress. Protocols for the management of end-of-life symptoms in the delivery room are used in current practice with very few validation studies. The protocol used in delivery rooms in Alsace uses fentanyl and midazolam intranasally. It has been used for 3 years and seems to provide satisfactory relief to newborn babies. In doing so, it seems to reassure parents about the quality of support and it seems to meet the expectations of professionals in these anxiety-provoking contexts. Scientific validation of these practices would allow wider dissemination to other maternity teams.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFebruary 2, 2022
January 1, 2022
Same day
January 18, 2022
February 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in pain
Evaluate the effectiveness of the current protocol for the management of pain and discomfort related to end-of-life respiratory distress in newborns receiving palliative care in the delivery room with (Neonatal Facial Coding System) NFCS score
1 day
DRFV scores
Presence of DRFV with Silverman score
1 day
Interventions
Application of the care protocol and data collection
Eligibility Criteria
Premature or term newborn in the delivery room
You may qualify if:
- Premature or term newborn
- In the delivery room
- In palliative care
- No parental opposition to data collection
You may not qualify if:
- Parental refusal or inability to express their consent
- Minor parents
- Very probable survival beyond the delivery room
- Impossibility of giving informed information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Subject under safeguard of justice
- Subject under guardianship or curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 67091, France
Service de pédiatrie - Hôpitaux Civils de Colmar
Colmar, 68020, France
Service de pédiatrie - Hôpitaux Civils de Haguenau
Haguenau, 67500, France
Service de Néonatologie- Centre Hospitalier de Mulhouse
Mulhouse, 68100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre KUHN
les Hôpitaux Universitaires de Strasbourg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2022
First Posted
February 2, 2022
Study Start
February 1, 2022
Primary Completion
February 1, 2022
Study Completion
February 1, 2023
Last Updated
February 2, 2022
Record last verified: 2022-01