Neonatal Respiratory DistressSUPREMEneoNCT06356909
Study of PREMEdication Before Laryngoscopy in Neonates in France
An observational study of Neonatal Respiratory Distress, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units… Read more about this study
- Who is it for?
- Ages 20 to 44 weeks
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Survey of sedo-analgesia practices before laryngoscopy
- How many people
- 741 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to 7 Apr 2024
- 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 20 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Every neonate (corrected gestational age < 45 weeks of gestation) that undergoes a laryngoscopy (for intubation or LISA) or a laryngeal mask insertion, that received a premedication or not during the 28 days of the survey. The survey will be proposed to all French neonatal intensive care units (n=67), intensive care units (n=87) and pediatric transport teams (n=35) prior to the survey.
Who may be able to join
- Every neonate (corrected gestational age < 45 weeks of gestation) that undergoes a laryngoscopy (for intubation or LISA) or a laryngeal mask insertion, that received a premedication or not during the 28 days of the survey.
Who cannot join
- Laryngoscopy or laryngeal mask insertion in the operating room
- Opposition to data collection of a parent or holder of parental rights
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of PREMEdication Before Laryngoscopy in Neonates in France: a National Prospective Survey in French Neonatal Units and Neonatal Transport Teams
This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety)
Read the detailed description
Laryngoscopy for intubation or less invasive surfactant administration (LISA) in neonates is a stressful and painful procedure that necessitates a sedo-analgesia except in the case of an immediate life-threatening emergency. Nevertheless, there are discrepancies in premedication practices amongst neonatal units. In order to optimize analgesia before laryngoscopy in neonates, the French neonatal society issued best practice guidelines in January 2023 for premedication before laryngoscopy in neonates. These guidelines were published in an English peer-reviewed journal and presented in national conferences. However, the implementation of new premedication protocols in neonatal units can be made difficult due to local habits, poor dissemination of the guidelines and a limited level of evidence on some premedication agents. Thus, conducting a survey one year after issuing the best practice guidelines on premedication seems important to evaluate French premedication practices and to evaluate the impact and dissemination of the guidelines
- Conditions
- Neonatal Respiratory Distress
- Being tested
- Survey of sedo-analgesia practices before laryngoscopy
- Keywords
- Sedo-analgesia, laryngoscopy, neonatal ICU, intubation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey of sedo-analgesia practices before laryngoscopyOther
The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement
Measured: Immediately after the laryngoscopy
Secondary outcomes (6)
Molecules used for sedo-analgesia
Measured: Immediately after the laryngoscopy
Cumulative doses of sedo-analgesia used
Measured: Immediately after the laryngoscopy
Questionnaire for the operator describing reasons for non-compliance with best practice guidelines
Measured: Immediately after the laryngoscopy
Numeric rating scale for pain (by operator and assistant)
Measured: Immediately after the laryngoscopy
TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment)
TRACHEA score from 0 to 10 where 0 represents adequate sedation with excellent conditions of intubation and 10 represents inadequate sedation with very poor conditions of intubation
Measured: Immediately after the laryngoscopy
Side effects related to the premedication
Measured: Immediately after the laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start11 Mar 2024
- Primary completion7 Apr 2024
- Study completion7 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- 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
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon TAUZIN, MD, Principal investigator, Centre hospitalier Intercommunal de Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356909
- Sponsor's protocol ID
- SUPREMEneo
- Acronym
- SUPREMEneo
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PREMEdication Before Laryngoscopy in Neonates in France: a National Prospective Survey in French Neonatal Units and Neonatal Transport Teams
- ClinicalTrials.gov ID
- NCT06356909
- Acronym / sponsor ID
- SUPREMEneo / SUPREMEneo
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Sedo-analgesia, laryngoscopy, neonatal ICU, intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 7 Apr 2024 (actual)
- First posted
- 10 Apr 2024 (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.
This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety)
Detailed description
Laryngoscopy for intubation or less invasive surfactant administration (LISA) in neonates is a stressful and painful procedure that necessitates a sedo-analgesia except in the case of an immediate life-threatening emergency. Nevertheless, there are discrepancies in premedication practices amongst neonatal units. In order to optimize analgesia before laryngoscopy in neonates, the French neonatal society issued best practice guidelines in January 2023 for premedication before laryngoscopy in neonates. These guidelines were published in an English peer-reviewed journal and presented in national conferences. However, the implementation of new premedication protocols in neonatal units can be made difficult due to local habits, poor dissemination of the guidelines and a limited level of evidence on some premedication agents. Thus, conducting a survey one year after issuing the best practice guidelines on premedication seems important to evaluate French premedication practices and to evaluate the impact and dissemination of the guidelines
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Every neonate (corrected gestational age < 45 weeks of gestation) that undergoes a laryngoscopy (for intubation or LISA) or a laryngeal mask insertion, that received a premedication or not during the 28 days of the survey. The survey will be proposed to all French neonatal intensive care units (n=67), intensive care units (n=87) and pediatric transport teams (n=35) prior to the survey.
Key inclusion criteria (1 listed)
- Every neonate (corrected gestational age < 45 weeks of gestation) that undergoes a laryngoscopy (for intubation or LISA) or a laryngeal mask insertion, that received a premedication or not during the 28 days of the survey.
Key exclusion criteria (2 listed)
- Laryngoscopy or laryngeal mask insertion in the operating room
- Opposition to data collection of a parent or holder of parental rights
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 |
|---|---|---|
| Survey of sedo-analgesia practices before laryngoscopyThe survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety) | Other | – |
Primary outcome
Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement
Time frame: Immediately after the laryngoscopy
6 secondary outcomes
Molecules used for sedo-analgesia
Time frame: Immediately after the laryngoscopy
Cumulative doses of sedo-analgesia used
Time frame: Immediately after the laryngoscopy
Questionnaire for the operator describing reasons for non-compliance with best practice guidelines
Time frame: Immediately after the laryngoscopy
Numeric rating scale for pain (by operator and assistant)
Time frame: Immediately after the laryngoscopy
TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment)
Time frame: Immediately after the laryngoscopy
Side effects related to the premedication
Time frame: Immediately after the laryngoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Manon TAUZIN, MD principal investigator
Centre hospitalier Intercommunal de Creteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Distress, run by Centre Hospitalier Intercommunal Creteil at 1 site 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement (time frame: Immediately after the laryngoscopy). 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 27 Aug 2025.