CompletedN/Aketamine

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

Sponsored by University Hospital, Montpellier

NCT ID
NCT03705468
Target Enrollment
71 participants
Start Date
2018-09-19
Est. Completion
2018-12-01

About This Study

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 Studied

Premature Neonate

Eligibility

Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Infant born below 30 wGA with RDS treated by CPAP requiring surfactant
* Available IV line
* Admission to the NICU of Montpellier University Hospital Centre in the first 24 hours of life

Exclusion Criteria:

* maternal general anesthesia

Study Locations (1)

Uhmontpellier
Montpellier, France

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source