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NCT05220644 Clinical Trial

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

Pain Clinical Trial

— PALLI-ACC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05220644
Other study ID # 8339
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2022
Est. completion date February 2023

Study information
Verified date January 2022
Source University Hospital, Strasbourg, France
Contact Pierre KUHN
Phone +33 3.88.12.77.85
Email Pierre.kuhn@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date February 2023
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Protocols for the management of end-of-life symptoms
Application of the care protocol and data collection

Locations
Country Name City State
France Service de pédiatrie - Hôpitaux Civils de Colmar Colmar
France Service de pédiatrie - Hôpitaux Civils de Haguenau Haguenau
France Service de Néonatologie- Centre Hospitalier de Mulhouse Mulhouse
France Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France Strasbourg Les Hôpitaux Universitaires De Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary DRFV scores Presence of DRFV with Silverman score 1 day
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