PALLI-ACC: Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05220644

Collaborator

(none)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Pain	Procedure: Protocols for the management of end-of-life symptoms

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Outcome Measures

Primary Outcome Measures

Change in pain [1 day]
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
DRFV scores [1 day]
Presence of DRFV with Silverman score

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Premature or term newborn
In the delivery room
In palliative care
No parental opposition to data collection

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France	Strasbourg	Les Hôpitaux Universitaires De Strasbourg	France	67091
2	Service de pédiatrie - Hôpitaux Civils de Colmar	Colmar		France	68020
3	Service de pédiatrie - Hôpitaux Civils de Haguenau	Haguenau		France	67500
4	Service de Néonatologie- Centre Hospitalier de Mulhouse	Mulhouse		France	68100

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator: Pierre KUHN, les Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT05220644

Other Study ID Numbers:

8339

First Posted:

Feb 2, 2022

Last Update Posted:

Feb 2, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Strasbourg, France

newborn

Additional relevant MeSH terms:

Death

Study Results

No Results Posted as of Feb 2, 2022