Clinical trial NCT03705468: Assessment of Ketamine and Propofol Sedation During LISA Method (Less Invasive Surfactant Administration)
Official title: Assessment of Kétamine and Propofol Sedation During Intra Tracheal Surfactant Administration by the LISA Method (Less Invasive Surfactant Administration)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Neonate
Keywords: Less Invasive Surfactant Administration (LISA)
Sedation
RDS treated by CPAP requiring surfactant
Sedation during intra tracheal surfactant administration by the LISA method
Available intravenous line
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infant born below 30 wGA with RDS treated by CPAP requiring surfactant and Available IV line

Brief 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.

Detailed description: Systematic reviews of the prospective studies performed suggest that among preterm infants, the use of LISA was associated with the lowest likelihood of the composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age when compared with the other ventilation strategies for preterm infants. Further studies are needed to optimize the indications and identify adequate strategies for premedication that preserve respiratory function and which limits pain and cardio-respiratory instability associated with laryngeal exposure without increasing risks of complications. According to a recent European survey, only 48% of neonatologists perform LISA with sedation. In a recent retrospective study, Dekker showed a more favorable COMFORTneo score with Propofol versus without, similar rates of intubation during LISA. Ketamine infusion has been used in several NICUs with few reported effects on respiratory function, but without publication. No prospective studies exist on LISA premedication. This study aims to optimize sedation during LISA in NICU patients with RDS. Comparing Ketamine and propofol sedation with rate of mechanical tracheal ventilation from the start of the LISA procedure up to 2 hours of life, in the NICU of Arnaud de Villeneuve University Hospital of Montpellier (France).

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

Primary outcomes:
measure: Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life
timeFrame: 2 hours after LISA procedure
Secondary outcomes:
measure: Cardiorespiratory parameters
timeFrame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
measure: Cardiorespiratory parameters
timeFrame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
measure: Cardiorespiratory parameters
timeFrame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
measure: Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure
timeFrame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
measure: To assess Neonatal morbidity at 36 wGA
timeFrame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
measure: To assess mortality at 36 wGA
timeFrame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: MILESI Christophe, PUPH
role: STUDY_DIRECTOR
References:
citation: Brotelande C, Milesi C, Combes C, Durand S, Badr M, Cambonie G. Premedication with ketamine or propofol for less invasive surfactant administration (LISA): observational study in the delivery room. Eur J Pediatr. 2021 Sep;180(9):3053-3058. doi: 10.1007/s00431-021-04103-1. Epub 2021 May 6.