- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220644
Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room (PALLI-ACC)
Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pierre KUHN
- Phone Number: +33 3.88.12.77.85
- Email: Pierre.kuhn@chru-strasbourg.fr
Study Locations
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-
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Colmar, France, 68020
- Service de pédiatrie - Hôpitaux Civils de Colmar
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Contact:
- Didier CHOGNOT
- Phone Number: +33 3.89.12.60.95
- Email: didier.chognot@ch-colmar.fr
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Haguenau, France, 67500
- Service de pédiatrie - Hôpitaux Civils de Haguenau
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Contact:
- Valérie KLEIN-AQUAFRESCA
- Phone Number: +33 3.88.06.30.47
- Email: valerie.klein@ch-haguenau.fr
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Sub-Investigator:
- Lydie DAVAL
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Mulhouse, France, 68100
- Service de Néonatologie- Centre Hospitalier de Mulhouse
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Contact:
- Amélie STERN-DELFILS
- Phone Number: +33 3.89.64.67.12
- Email: amelie.stern-delfils@ghrmsa.fr
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Les Hôpitaux Universitaires De Strasbourg
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Strasbourg, Les Hôpitaux Universitaires De Strasbourg, France, 67091
- Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France
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Contact:
- Pierre KUHN
- Phone Number: +33 3.88.12.77.85
- Email: Pierre.kuhn@chru-strasbourg.fr
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Sub-Investigator:
- Nadine COJEAN
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Sub-Investigator:
- Claire LANGLET
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Sub-Investigator:
- Nadine KNEZOVIC
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Sub-Investigator:
- Véronique DURST
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Sub-Investigator:
- Christine SCHEIB-BROLLY
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Sub-Investigator:
- Caroline TAVERNIER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain
Time Frame: 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
|
1 day
|
DRFV scores
Time Frame: 1 day
|
Presence of DRFV with Silverman score
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pierre KUHN, Les Hôpitaux Universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8339
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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