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

NCT03721640 | Completed DMC

• 2 other identifiers: 18CH1292018-003233-14
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyaline Membrane Disease; Preterm Infant

Keywords

INSURE (Intubation / surfactant / extubation); LISA (Less-invasive surfactant administration); surfactant; propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• heart rate

  during surfactant administration procedure

• systolic arterial blood pressure

  during surfactant administration procedure

• diastolic arterial blood pressure

  during surfactant administration procedure

• Oxygen saturation

  during surfactant administration procedure

Study Arms (1)

Preterm neonates (< 33 weeks GA)

Preterm neonates requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods.

Other: electrocardiogram

Interventions

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.

Preterm neonates (< 33 weeks GA)

Eligibility Criteria

• Age: Up to 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates (\< 33 weeks GA) admitted to the tertiary Neonatal Intensive Care Unit of Saint-Etienne hospital requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Hyaline Membrane Disease; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hugues PATURAL

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: February 25, 2019
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)