Status:
COMPLETED
Aerosolized Surfactant in Neonatal RDS
Lead Sponsor:
Sood, Beena G., MD, MS
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
PHASE2
Brief Summary
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 surfact...
Eligibility Criteria
Inclusion
- Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
- Gestational age of 240/7-366/7 weeks
- Postnatal age ≤ 24 hours
- 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
- Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
- Written informed consent from parent/guardian
Exclusion
- Previous receipt of surfactant
- Infants with respiratory distress who are unstable and require immediate intubation
- Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
- Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
- Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
- Neuromuscular disorder resulting in respiratory compromise
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT02294630
Start Date
December 1 2014
End Date
July 1 2020
Last Update
August 25 2021
Active Locations (1)
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1
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201