Respiratory DistressPALLI-ACCNCT05220644
Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room
An observational study of Respiratory Distress and Pain, run by University Hospital, Strasbourg, France at 4 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress, Pain
- What is being tested?
- Protocols for the management of end-of-life symptoms
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2022to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature or term newborn in the delivery room
Who may be able to join
- Premature or term newborn
- In the delivery room
- In palliative care
- No parental opposition to data collection
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de pédiatrie - Hôpitaux Civils de Colmar
Colmar, 68020
Didier CHOGNOT, +33 3.89.12.60.95, didier.chognot@ch-colmar.fr
Service de pédiatrie - Hôpitaux Civils de Haguenau
Haguenau, 67500
Valérie KLEIN-AQUAFRESCA, +33 3.88.06.30.47, valerie.klein@ch-haguenau.fr
Lydie DAVAL
Service de Néonatologie- Centre Hospitalier de Mulhouse
Mulhouse, 68100
Amélie STERN-DELFILS, +33 3.89.64.67.12, amelie.stern-delfils@ghrmsa.fr
Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 67091
Pierre KUHN, +33 3.88.12.77.85, Pierre.kuhn@chru-strasbourg.fr
Pierre KUHN
About this study
Official title: 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.
- Conditions
- Respiratory Distress, Pain
- Being tested
- Protocols for the management of end-of-life symptoms
- Keywords
- newborn
- Medical subject headings
- Dyspnea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocols for the management of end-of-life symptomsProcedure or surgery
Application of the care protocol and data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
DRFV scores
Presence of DRFV with Silverman score
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre KUHN, Principal investigator, les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220644
- Sponsor's protocol ID
- 8339
- Acronym
- PALLI-ACC
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the
- ClinicalTrials.gov ID
- NCT05220644
- Acronym / sponsor ID
- PALLI-ACC / 8339
- Conditions
- Respiratory Distress, Pain
- Keywords
- newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature or term newborn in the delivery room
Key inclusion criteria (4 listed)
- Premature or term newborn
- In the delivery room
- In palliative care
- No parental opposition to data collection
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocols for the management of end-of-life symptomsApplication of the care protocol and data collection | Procedure or surgery | – |
Primary outcome
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
DRFV scores
Time frame: 1 day
Presence of DRFV with Silverman score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
Related trials for Respiratory Distress
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre KUHN principal investigator
les Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress and Pain, run by University Hospital, Strasbourg, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre KUHN (+33 3.88.12.77.85, Pierre.kuhn@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.