Study of PREMEdication Before Laryngoscopy in Neonates in France

NCT06356909 | Completed

• 1 other identifier: SUPREMEneo
• Study Type: observational
• Target: 741
• Locations: 1 country
• Sites: 1

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)

Conditions

Neonatal Respiratory Distress

Keywords

Sedo-analgesia; laryngoscopy; neonatal ICU; intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Molecules used for sedo-analgesia

  Immediately after the laryngoscopy

• 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

• 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

Interventions

Survey of sedo-analgesia practices before laryngoscopy OTHER

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

• Age: 20 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Creteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Manon TAUZIN, MD

  Centre hospitalier Intercommunal de Creteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 10, 2024
• Study Start: March 11, 2024
• Primary Completion: April 7, 2024
• Study Completion: April 7, 2024
• Last Updated: August 27, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)