Study of PREMEdication Before Laryngoscopy in Neonates in France (SUPREMEneo)

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Neonatal Respiratory Distress

Treatments: Other: Survey of sedo-analgesia practices before laryngoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT06356909

SUPREMEneo

Details and patient eligibility

About

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)

Full 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

Enrollment: 900 estimated patients

Sex: All

Ages: 20 to 44 weeks old

Volunteers: No Healthy Volunteers

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