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

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ClinicalTrials.gov Identifier: NCT03721640
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Hyaline Membrane Disease Preterm Infant Other: electrocardiogram

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Group/Cohort Intervention/treatment
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
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721640


Contacts
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Contact: Hugues PATURAL 04 77 82 85 42 ext +33 hugues.patural@chu-st-etienne.fr

Locations
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France
CHU de Saint Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Hugues PATURAL, MD PhD    04 77 82 85 42 ext +33    hugues.patural@chu-st-etienne.fr   
Principal Investigator: Hugues PATURAL, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Hugues PATURAL CHU de Saint Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03721640    
Other Study ID Numbers: 18CH129
2018-003233-14 ( EudraCT Number )
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
INSURE (Intubation / surfactant / extubation)
LISA (Less-invasive surfactant administration)
surfactant
propofol
Additional relevant MeSH terms:
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Hyaline Membrane Disease
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases