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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-19

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Premature Neonate

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ketamine sedation

No interventions assigned to this group

Propofol sedation

No interventions assigned to this group

Eligibility Criteria

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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