Study of PREMEdication Before Laryngoscopy in Neonates in France

Last updated: April 4, 2024
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Survey of sedo-analgesia practices before laryngoscopy

Clinical Study ID

NCT06356909
SUPREMEneo
  • Ages 20-44
  • All Genders

Study 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 (agents, dosing, efficacy, safety)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Every neonate (corrected gestational age < 45 weeks of gestation) that undergoes alaryngoscopy (for intubation or LISA) or a laryngeal mask insertion, that received apremedication or not during the 28 days of the survey.

Exclusion

Exclusion Criteria:

  • Laryngoscopy or laryngeal mask insertion in the operating room
  • Opposition to data collection of a parent or holder of parental rights

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Survey of sedo-analgesia practices before laryngoscopy
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
April 07, 2024

Study 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

Connect with a study center

  • Centre Hospitalier Intercommunal de Creteil

    Creteil, 94000
    France

    Active - Recruiting

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