Study of PREMEdication Before Laryngoscopy in Neonates in France

NCT ID: NCT06356909

Last Updated: 2025-08-27

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

COMPLETED

Total Enrollment

741 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-11

Study Completion Date

2024-04-07

Brief Summary

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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

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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

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Neonatal Respiratory Distress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Survey of sedo-analgesia practices before laryngoscopy

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Laryngoscopy or laryngeal mask insertion in the operating room
* Opposition to data collection of a parent or holder of parental rights
Minimum Eligible Age

20 Weeks

Maximum Eligible Age

44 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manon TAUZIN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier Intercommunal de Creteil

Locations

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Centre Hospitalier Intercommunal de Creteil

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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SUPREMEneo

Identifier Type: -

Identifier Source: org_study_id

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