Aerosolized Surfactant in Neonatal RDS

Completed · Phase 1/Phase 2

Conditions studied: Respiratory Distress Syndrome, Newborn

In brief

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.

Key facts

Study ID

NCT02294630

Run by

Sood, Beena G., MD, MS

People needed

159

Starts

2014-12-01

Expected to finish

2020-07-01

Last updated by the study team

2021-08-25

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hutzel Women's Hospital — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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