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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03705468
Acronym
ANALISA
Enrollment
71
Registered
2018-10-15
Start date
2018-09-19
Completion date
2018-12-01
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life2 hours after LISA procedureThe 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

Secondary

MeasureTime frameDescription
Cardiorespiratory parameters5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational ageCardiorespiratory parameters before and at 5, 30 minutes after the drug injection: blood pressure
Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational ageRate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure (apnea, need surfactant)
To assess Neonatal morbidity at 36 wGA5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational ageNeonatal morbidity at 36 wGA
To assess mortality at 36 wGA5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational ageMortality at 36 wGA

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026