Aerosolized Surfactant in Neonatal RDS
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/8/2018 |
| Start Date: | December 2014 |
| End Date: | June 2019 |
Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study
Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of
mortality and morbidity in preterm infants. Intratracheal instillation, the only approved
means of surfactant delivery, requires endotracheal intubation and mechanical ventilation
with their attendant risks. Interventions that decrease need for intubation and mechanical
ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway
pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are
increasingly being used for initial respiratory support in preterm neonates with RDS to
improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising
concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar
recruitment while obviating the risks of intubation and mechanical ventilation. The
investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in
preterm infants undergoing NIV is safe and feasible and will result in short-term improvement
in oxygenation and ventilation. The objective of this proposal is to perform a single-center
unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of
RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.
mortality and morbidity in preterm infants. Intratracheal instillation, the only approved
means of surfactant delivery, requires endotracheal intubation and mechanical ventilation
with their attendant risks. Interventions that decrease need for intubation and mechanical
ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway
pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are
increasingly being used for initial respiratory support in preterm neonates with RDS to
improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising
concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar
recruitment while obviating the risks of intubation and mechanical ventilation. The
investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in
preterm infants undergoing NIV is safe and feasible and will result in short-term improvement
in oxygenation and ventilation. The objective of this proposal is to perform a single-center
unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of
RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.
Inclusion Criteria:
1. Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of
Michigan (CHM)
2. Gestational age of 240/7-366/7 weeks
3. Postnatal age ≤ 24 hours
4. Clinical diagnosis of RDS based on (i) presence of at least two of the four classic
symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or
grunting), and (ii) exclusion of other causes of respiratory failure and (iii)
Clinician intent to administer surfactant if infant requires intubation
5. Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20
or HFNC rate ≥ 2 LPM for ≤8 hours
6. Written informed consent from parent/guardian
Exclusion Criteria:
1. Previous receipt of surfactant
2. Infants with respiratory distress who are unstable and require immediate intubation
3. Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
4. Lethal congenital malformations; death anticipated within first 3 days of life;
decision to withhold support
5. Serious abdominal, cardiac, airway or respiratory malformations including tracheal
esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary
hypoplasia, or diaphragmatic hernia
6. Neuromuscular disorder resulting in respiratory compromise
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