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

• Conditions: Respiratory Distress; Pain

• Registration Number: NCT05220644
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-18
• Study Start: 2022-02
• Primary Completion: 2022-02
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France; 🇫🇷 Strasbourg, Les Hôpitaux Universitaires De Strasbourg, 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