E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
population of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactant |
Prématuré < 33 SA nécessitant une intubation en vue de l'administration de surfactant exogène |
|
E.1.1.1 | Medical condition in easily understood language |
population of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactant |
Prématuré < 33 SA nécessitant une intubation en vue de l'administration de surfactant exogène |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003969 |
E.1.2 | Term | Baby premature |
E.1.2 | System Organ Class | 100000004868 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020477 |
E.1.2 | Term | Hyaline membrane disease |
E.1.2 | System Organ Class | 100000004855 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002321 |
E.1.2 | Term | Anesthesia |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
évaluer pour des prématurés de moins de 33 SA l’effet du propofol (Diprivan®) sur les variations des indices autonomiques de stress et notamment sur l’indice LF au cours d’une séquence d’intubation et administration de surfactant. |
|
E.2.2 | Secondary objectives of the trial |
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. |
évaluer l’effet du propofol (Diprivan®) sur les variations des autres indices autonomiques et hémodynamiques de stress au cours de cette même séquence : pression artérielle moyenne (mmHg) fréquence cardiaque (bpm), la saturation en oxygène (%) et les autres indices linéaires et non-linéaires de variabilité de la fréquence cardiaque. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Preterm neonates (< 33 weeks GA) requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods. • Collected Consent from parents
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• Nouveau-né prématuré de 33 SA ou moins nécessitant une intubation en vue de l’administration de surfactant exogène par la procédure INSURE ou LISA dans la première semaine de vie. • Consentement signé par les parents ou le titulaire de l’autorité parentale |
|
E.4 | Principal 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
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• Nouveau-né présentant une hémorragie intra-ventriculaire de grade 3 ou 4 • Nouveau-né présentant une instabilité hémodynamique • Nouveau-né atteint de cardiopathie congénitale • Nouveau-né présentant une malformation congénitale majeure • Nouveau-né étant déjà intubé, sédaté sous ventilation mécanique invasive |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Real-time LF values (low frequency) calculated from the ECG plot and the R-R interval |
indice LF calculé à partir du tracé ECG et de l’intervalle R-R |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
during the intubation procedure |
pendant la procédure d'intubation |
|
E.5.2 | 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
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• Indices de fréquence cardiaque et autres indices de variabilité du taux de chaleur mesurés à partir de l'électro-tachogramme • Saturation en oxygène mesurée par oxymétrie de pouls • La pression sanguine artérielle systolique, diastolique et moyenne (MAP) a mesuré un brassard |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
during the intubation procedure |
pendant la procédure d'intubation |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
dernière visite dernier sujet |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |