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Completed

NCT Number: NCT03721640

Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA

Hyaline membrane disease is one of the leading causes of morbidity and mortality in premature newborns in industrialized countries. For 30 years, the management of the hyaline membranes disease has been transformed by intratracheal administration of exogenous surfactant (Curosurf®) at birth or in the following hours. In order to limit the harmful effects in terms of barotrauma of mechanical ventilation, several methods have been developed over the last decades, aiming at limiting the mechanical ventilation to the profile of non-invasive ventilation: Thus the administration of surfactant has become faster (although invasive) and if possible followed by immediate extubation following the INSURE (INtubation / SURfactant / Extubation) or LISA (Less-Invasive Surfactant Administration) procedure.

Given the fragility of the children concerned and their low weight, this invasive gesture has long been carried out without premedication. However, taking into account the pain induced and potential hemodynamic consequences of the gesture, neonatal societies now recommend the use of anesthetic before intubation, with a short duration sedative.

Propofol is a general anesthetic that combines these conditions and is widely used in pediatric anesthesia.

In that way, since 2016, the invetigators have modified the sedation protocol for intubation in our department and have recommended Propofol as first-line treatment for term and preterm newborn. A lot of study showed its hemodynamic safety in preterms. However, the investigators lack data on the autonomic stress really observed during intubation in this population. The investigators therefore propose to evaluate these physiological data in a non-randomized prospective observational study in premature infants under 33 weeks of gestational amenorrhea (GA), during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique, with standardized doses of propofol : 1mg/kg for preterm infants with a birthweight less than 1.5kg and 1.5mg/kg for higher birthweight.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • breathing rate > 60 cycles/min
  • Silverman scale > 3 and < 6
  • FiO2 > 30% and < 60%
  • collected consent from parents

Exclusion criteria

  • Preterm neonates with Intraventricular hemorrhage grade III & IV
  • Preterm neonates with hemodynamic instability
  • Preterm neonates with congenital heart disease
  • Preterm neonates with severe congenital malformation
  • Preterm neonates already sedated and/or under invasive mechanical ventilation
  • FiO2 > 60%
  • Silverman scale > 6
  • Use of amines for maintaining blood pressure
  • Use of sedatives or analgesics during the last 24 hours (except paracetamol and ibuprofen)

Treatment and study plan

Electrocardiogram

Other

Autonomic and hemodynamic evaluation with different indices (LF, heart rate, Systolic, diastolic and mean arterial blood pressure, SaO2) during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique.

Primary outcomes

  1. Real-time LF values (low frequency)

    Time frame: during surfactant administration procedure

    • represent the well-being sympathetic activity of the autonomic nervous system
    • measured with electrocardiogram

Secondary outcomes

  1. heart rate

    Time frame: during surfactant administration procedure

    • measured with electrocardiogram
  2. systolic arterial blood pressure

    Time frame: during surfactant administration procedure

    • measured with a blood pressure cuff
  3. diastolic arterial blood pressure

    Time frame: during surfactant administration procedure

    • measured with a blood pressure cuff
  4. Oxygen saturation

    Time frame: during surfactant administration procedure

    • measured by pulse oximetry

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PROPOSURF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2018
Registry last updated
Mar 4, 2024

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

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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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