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

Assessment of Kétamine and Propofol Sedation During Intra Tracheal Surfactant Administration by the LISA Method (Less Invasive Surfactant Administration)

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.

Study Overview

• Status: Completed
• Conditions: Premature Neonate

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).

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infant born below 30 wGA with RDS treated by CPAP requiring surfactant and Available IV line

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ketamine sedation
Propofol sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life	The Investigators would like to evaluating the need for MV within the time of the LISA procedure and up to 2 hours of life among preterm babies less than 30wGA	2 hours after LISA procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory parameters	Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: blood pressure	5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Cardiorespiratory parameters	Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: FiO2	5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Cardiorespiratory parameters	Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: heart rate	5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure	Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure (apnea, need surfactant)	5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
To assess Neonatal morbidity at 36 wGA	Neonatal morbidity at 36 wGA	5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
To assess mortality at 36 wGA	Mortality at 36 wGA	5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: MILESI Christophe, PUPH, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2018
• Primary Completion (ACTUAL): October 30, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (ACTUAL): October 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Sedation; Less Invasive Surfactant Administration (LISA); RDS treated by CPAP requiring surfactant; Sedation during intra tracheal surfactant administration by the LISA method; Available intravenous line
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: RECHMPL18_0340

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No