Evaluation of the neonatal autonomic stress during intubations under Propofol in a population of premature infants under 33 w’GA

Evaluation of the neonatal autonomic stress during intubations under Propofol in a population of premature infants under 33 w’GA - PROPOSURF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003233-14-FR

Enrollment

Registered

2018-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

population of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactant MedDRA version: 20.0 Level: LLT Classification code 10003969 Term: Baby premature System Organ Class: 100000004868 MedDRA version: 20.0 Level: LLT Classification code 10020477 Term: Hyaline membrane disease System Organ Class: 100000004855 MedDRA version: 20.1 Level: LLT Classification code 10002321 Term: Anesthesia System Organ Class: 100000004852

Interventions

Trade Name: Diprivan Product Name: propofol Pharmaceutical Form: Emulsion for injection Trade Name: Atropine sulfate Product Name: sulfate d'atropine Pharmaceutical Form: Solution for injection Trad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Preterm neonates (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate for premature infants less than 33 AS the effect of propofol (Diprivan®) on the autonomic stress variations and in particular on the LF index during an intubation sequence and surfactant administration.;Secondary Objective: evaluate the effect of propofol (Diprivan®) on the variations of the other autonomic and hemodynamic indices of stress during this same sequence: mean arterial pressure (mmHg) heart rate (bpm), oxygen saturation (%) and the others linear and non-linear indices of variability of heart rate.;Primary end point(s): Real-time LF values (low frequency) calculated from the ECG plot and the R-R interval;Timepoint(s) of evaluation of this end point: during the intubation procedure	—

Measure

Time frame

Main Objective: evaluate for premature infants less than 33 AS the effect of propofol (Diprivan®) on the autonomic stress variations and in particular on the LF index during an intubation sequence and surfactant administration.;Secondary Objective: evaluate the effect of propofol (Diprivan®) on the variations of the other autonomic and hemodynamic indices of stress during this same sequence: mean arterial pressure (mmHg) heart rate (bpm), oxygen saturation (%) and the others linear and non-linear indices of variability of heart rate.;Primary end point(s): Real-time LF values (low frequency) calculated from the ECG plot and the R-R interval;Timepoint(s) of evaluation of this end point: during the intubation procedure

—

Secondary

Measure	Time frame
Secondary end point(s): • Heart rate and others heat rate variability indices measured from the electro-tachogram • Oxygen saturation measured by pulse oximetry • Systolic, diastolic and mean arterial blood pressure (MAP) measured a blood pressure cuff ;Timepoint(s) of evaluation of this end point: during the intubation procedure	—

Countries

France

Contacts

Public Contactproject manager

CHU de Saint Etienne

marie.peuriere@chu-st-etienne.fr0477829272+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026