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Completed

NCT Number: NCT06356909

Study of PREMEdication Before Laryngoscopy in Neonates in France

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)

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Key information

Age range

20 week–44 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal de Creteil

Créteil, 94000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

    Time frame: Immediately after the laryngoscopy

Secondary outcomes

  1. Molecules used for sedo-analgesia

    Time frame: Immediately after the laryngoscopy

  2. Cumulative doses of sedo-analgesia used

    Time frame: Immediately after the laryngoscopy

  3. Questionnaire for the operator describing reasons for non-compliance with best practice guidelines

    Time frame: Immediately after the laryngoscopy

  4. Numeric rating scale for pain (by operator and assistant)

    Time frame: Immediately after the laryngoscopy

  5. TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment)

    Time frame: 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

  6. Side effects related to the premedication

    Time frame: Immediately after the laryngoscopy

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: SUPREMEneo

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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