Clinical trial NCT06356909: Study of PREMEdication Before Laryngoscopy in Neonates in France
Official title: Study of PREMEdication Before Laryngoscopy in Neonates in France: a National Prospective Survey in French Neonatal Units and Neonatal Transport Teams
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Respiratory Distress
Keywords: Sedo-analgesia
laryngoscopy
neonatal ICU
intubation
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 900
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement
timeFrame: Immediately after the laryngoscopy
Secondary outcomes:
measure: Molecules used for sedo-analgesia
timeFrame: Immediately after the laryngoscopy
measure: Cumulative doses of sedo-analgesia used
timeFrame: Immediately after the laryngoscopy
measure: Questionnaire for the operator describing reasons for non-compliance with best practice guidelines
timeFrame: Immediately after the laryngoscopy
measure: Numeric rating scale for pain (by operator and assistant)
timeFrame: Immediately after the laryngoscopy
measure: TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment)
timeFrame: Immediately after the laryngoscopy
measure: Side effects related to the premedication
timeFrame: Immediately after the laryngoscopy
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
Study officials:
affiliation: Centre hospitalier Intercommunal de Creteil
name: Manon TAUZIN, MD
role: PRINCIPAL_INVESTIGATOR
References: