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

Preterm Infant Clinical Trial

— PROPOSURF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721640
• Other study ID #: 18CH129
• Secondary ID: 2018-003233-14
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: August 23, 2022

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 33 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Preterm Infant

Intervention

Other:
• electrocardiogram
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.

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-time LF values (low frequency)	represent the well-being sympathetic activity of the autonomic nervous system; measured with electrocardiogram	during surfactant administration procedure
Secondary	heart rate	- measured with electrocardiogram	during surfactant administration procedure
Secondary	systolic arterial blood pressure	- measured with a blood pressure cuff	during surfactant administration procedure
Secondary	diastolic arterial blood pressure	- measured with a blood pressure cuff	during surfactant administration procedure
Secondary	Oxygen saturation	- measured by pulse oximetry	during surfactant administration procedure