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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Death
• Pain
• Respiratory Distress

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