MedTrace Logo

Assessment of Ketamine and Propofol Sedation During LISA Method (Less Invasive Surfactant Administration)

NCT03705468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2019-04-18

No results posted yet for this study

Summary

Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA). The strategy to manage RDS relies on the use of surfactant and non-invasive nasal ventilation, to limit tracheal mechanical ventilation. During recent years, surfactant administration through a thin catheter in spontaneously breathing preterm used in association with continuous positive airway pressure (CPAP) has emerged as a new approach for treating neonates with respiratory failure. The main objectives of Less Invasive Surfactant Administration (LISA) are to avoid endotracheal mechanical ventilation and its side effects including bronchopulmonary dysplasia. The LISA premedication procedure still under debate, because only 1 trial use analgesia or sedation during procedure. This reflects neonatologists concerns about side effects (apnea and the need for mechanical ventilation) of this premedication. This study aims to optimize sedation during LISA procedure by evaluating pain score with Ketamine or Protofol sedation, in Neonatal intensive care unit (NICU) patients with RDS.

Conditions

  • Premature Neonate

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • MILESI Christophe, PUPH · University Hospital, Montpellier

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2018-10-30
Completion
2018-12-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705468 on ClinicalTrials.gov