Respiratory Distress Syndrome
Conditions
Keywords
RDS, Surfactant, Threshold, Oxygen, Preterm, Infant
Brief summary
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.
Detailed description
Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear. In this single-center, randomized, phase 4 trial, preterm infants (gestational age\<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.
Interventions
DRUGPoractant Alfa 80 mg/mL Intratracheal Suspension
Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.
Sponsors
Virgilio Paolo Carnielli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be masked.
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* gestational age less than 32 weeks; * diagnosis of respiratory distress (RDS); * need for ventilatory support; * written informed consent.
Exclusion criteria
* congenital malformations; * genetic disorders; * perinatal asphyxia. * neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory pulmonary function | At day 3 of life | The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen therapy | At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first | The need of oxygen therapy |
| Respiratory Support-1 | At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first | The need of respiratory support |
| Respiratory severity-1 | At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first | Silvermann score as secondary respiratory severity index |
| Endotracheal intubation | At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first | The need of endotracheal intubation after surfactant administration |
| Long-term respiratory pulmonary function | At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age | The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR) |
| Complications of prematurity | From birth to 36 weeks of postmenstrual age or discharge if it occurred first | The incidence of intraventricular hemorrhage of grade 3-4, periventricular leukomalacia, bronchopulmonary dysplasia, sepsis and retinopathy of prematurity |
| In-hospital death | From birth to 36 week of gestation or discharge if it occurred first | death before 36 weeks of gestation |
| Respiratory severity-2 | At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first | Lung ultrasound score (LUS) score as secondary respiratory severity index |
Contacts
Primary ContactVirgilio Carnielli, MD, PHD
Backup ContactValentina Dell'Orto, MD
Outcome results
None listed