Skip to content

Study of PREMEdication Before Laryngoscopy in Neonates in France

Study of PREMEdication Before Laryngoscopy in Neonates in France: a National Prospective Survey in French Neonatal Units and Neonatal Transport Teams

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06356909
Acronym
SUPREMEneo
Enrollment
741
Registered
2024-04-10
Start date
2024-03-11
Completion date
2024-04-07
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Respiratory Distress

Keywords

Sedo-analgesia, laryngoscopy, neonatal ICU, intubation

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

Interventions

OTHERSurvey 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)

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Weeks to 44 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placementImmediately after the laryngoscopy

Secondary

MeasureTime frameDescription
Cumulative doses of sedo-analgesia usedImmediately after the laryngoscopy
Questionnaire for the operator describing reasons for non-compliance with best practice guidelinesImmediately after the laryngoscopy
Molecules used for sedo-analgesiaImmediately after the laryngoscopy
TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment)Immediately after the laryngoscopyTRACHEA 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 premedicationImmediately after the laryngoscopy
Numeric rating scale for pain (by operator and assistant)Immediately after the laryngoscopy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026