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

NCT ID: NCT05220644

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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Respiratory Distress Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Protocols for the management of end-of-life symptoms

Application of the care protocol and data collection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre KUHN

Role: PRINCIPAL_INVESTIGATOR

les Hôpitaux Universitaires de Strasbourg

Locations

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Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France

Strasbourg, Les Hôpitaux Universitaires de Strasbourg, France

Site Status

Service de pédiatrie - Hôpitaux Civils de Colmar

Colmar, , France

Site Status

Service de pédiatrie - Hôpitaux Civils de Haguenau

Haguenau, , France

Site Status

Service de Néonatologie- Centre Hospitalier de Mulhouse

Mulhouse, , France

Site Status

Countries

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France

Central Contacts

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Pierre KUHN

Role: CONTACT

+33 3.88.12.77.85

Facility Contacts

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Pierre KUHN

Role: primary

+33 3.88.12.77.85

Didier CHOGNOT

Role: primary

+33 3.89.12.60.95

Valérie KLEIN-AQUAFRESCA

Role: primary

+33 3.88.06.30.47

Amélie STERN-DELFILS

Role: primary

+33 3.89.64.67.12

Other Identifiers

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8339

Identifier Type: -

Identifier Source: org_study_id

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