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NCT Number: NCT03705468

Assessment of Ketamine and Propofol Sedation During 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.

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Key information

Conditions

Premature Neonate Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life

    Time frame: 2 hours after LISA procedure

    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

Secondary outcomes

  1. Cardiorespiratory parameters

    Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age

    Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: blood pressure

  2. Cardiorespiratory parameters

    Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age

    Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: FiO2

  3. Cardiorespiratory parameters

    Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age

    Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: heart rate

  4. Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure

    Time frame: 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 (apnea, need surfactant)

  5. To assess Neonatal morbidity at 36 wGA

    Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age

    Neonatal morbidity at 36 wGA

  6. To assess mortality at 36 wGA

    Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age

    Mortality at 36 wGA

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ANALISA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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