treatment of at term or late preterm newborn infants with severe respiratory disorders and pulmonary hypertension Level: PT Classification code 10037400
Conditions
Interventions
Trade Name: REVATIO
Pharmaceutical Form: Oral solution
INN or Proposed INN: Sildenafil
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 1-
Pharmaceutical
Sponsors
OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: neonates ≥34 weeks of gestational age hospitalized in neonatal intensive care units (NICU) within the first week of life with acute respiratory failure of any origin, who require mechanical ventilation, either conventional (tidal) or high frequency oscillatory (HFOV), with an OI ≥10 and echocardiographic evidence of PH. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: major malformation, genetic/chromosomic anomalies incompatible with life or with increased risk of unfavorable neurological outcome, systemic hypotension (mean arterial blood pressure <2 SD the average value for birth weight [8], intracranial hemorrhage, previous iNO exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study primary aim is to assess whether the use of sildenafil in term or late preterm (≥34 weeks) neonates with severe hypoxemia associated with persistent pulmonary hypertension (PH) improves oxygenation and decreases right ventricular pressure without increasing the incidence of side effects such as systemic arterial hypotension.;Secondary Objective: Secondary objective are: in-hospital mortality and incidence of long-term outcomes (neurosensorial, auxological and respiratory impairments) not higher than those observed without the administration of sildenafil or following the use of iNO. The evaluation of some process indicators will be also performed, such as duration of mechanical ventilation, frequency of administration and dosage of inotropic drugs, amount and duration of iNO if used, hospitalization lenght. We expect these indicators to be reduced in sildenafil-treated infants, compared to non-treated ones.;Primary end point(s): a) ≥10 units OI reduction after treatment onset. OI will be determined at inclusion (time point 0), then every 6 hours, within 30? from the following S/P dose (time points 1 to 7), then 6 hours after the last dose (time point 8), then, lastly, 24 hours after (time point 9), through arterial blood sampling for PaO2 measurement, mean airway pressure (MAP) and FiO2 readings. Considering a maximum of 0.5 mL per sample, the total amount of blood drawn will be 5 mL for each subject. b) PP reduction. PP will be evaluated by echocardiography through doppler tricuspid regurgitation flow velocity if present, or through intra-ventricular septum configuration (flattened or left-bowed septum). PP will be evaluated at time point 0, then every 24 hours for 3 measurements (thus, the last evaluation will be performed 24 hours after last S/P administration, and will match the last OI determination). c) Systemic arterial hypotension. Arterial blood pressure will be measured non-invasively and expressed in mm Hg; it will be | — |
Countries
Italy
Outcome results
None listed