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

Premature Neonate Clinical Trial

— ANALISA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705468
• Other study ID #: RECHMPL18_0340
• Status: Completed
• Start date: September 19, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 1, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Neonate

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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