Study of PREMEdication Before Laryngoscopy in Neonates in France

Neonatal Respiratory Distress Clinical Trial

— SUPREMEneo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356909
• Other study ID #: SUPREMEneo
• Status: Recruiting
• Start date: March 11, 2024
• Est. completion date: April 7, 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Manon TAUZIN, MD
• Phone: 0157023458
• Email: manon.tauzin[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: April 7, 2024
• Est. primary completion date: April 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Weeks to 44 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Survey 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)

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Creteil	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

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