Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room (PALLI-ACC)

February 1, 2022 updated by: University Hospital, Strasbourg, France

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Colmar, France, 68020
        • Service de pédiatrie - Hôpitaux Civils de Colmar
        • Contact:
      • Haguenau, France, 67500
        • Service de pédiatrie - Hôpitaux Civils de Haguenau
        • Contact:
        • Sub-Investigator:
          • Lydie DAVAL
      • Mulhouse, France, 68100
        • Service de Néonatologie- Centre Hospitalier de Mulhouse
        • Contact:
    • Les Hôpitaux Universitaires De Strasbourg
      • Strasbourg, Les Hôpitaux Universitaires De Strasbourg, France, 67091
        • Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France
        • Contact:
        • Sub-Investigator:
          • Nadine COJEAN
        • Sub-Investigator:
          • Claire LANGLET
        • Sub-Investigator:
          • Nadine KNEZOVIC
        • Sub-Investigator:
          • Véronique DURST
        • Sub-Investigator:
          • Christine SCHEIB-BROLLY
        • Sub-Investigator:
          • Caroline TAVERNIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature or term newborn in the delivery room

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Pierre KUHN, Les Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2022

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (ACTUAL)

February 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

January 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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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