Study of PREMEdication Before Laryngoscopy in Neonates in France

Recruiting

• Conditions: Neonatal Respiratory Distress

• Registration Number: NCT06356909
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief 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)

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 Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Primary Completion: 2024-04-07
• Study Completion: 2024-04-07
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement	Immediately after the laryngoscopy

Secondary Outcome Measures

Name	Time	Method
Cumulative doses of sedo-analgesia used	Immediately after the laryngoscopy
Questionnaire for the operator describing reasons for non-compliance with best practice guidelines	Immediately after the laryngoscopy
Molecules used for sedo-analgesia	Immediately after the laryngoscopy
Numeric rating scale for pain (by operator and assistant)	Immediately after the laryngoscopy
TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment)	Immediately after the laryngoscopy	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
Side effects related to the premedication	Immediately after the laryngoscopy

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Creteil; 🇫🇷 Creteil, France