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Aerosolized Surfactant in Neonatal RDS | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Aerosolized Surfactant in Neonatal RDS

Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study

NCT02294630•Sood, Beena G., MD, MS

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 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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Hutzel Women's Hospital

Detroit, Michigan, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

July 1, 2019

Completion Date

July 1, 2020

Last Updated

August 25, 2021

Enrollment

159

ACTUAL participants

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Surfactant

DRUG

Prophylactic Minimally Invasive Surfactant Evaluation

NCT06007547

Respiratory Distress Syndrome, NewbornPremature Birth

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COMPLETED

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

NCT05260424

Respiratory Distress Syndrome, NewbornPremature

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Aerosolized Surfactant in Neonatal RDS

Inclusion Criteria

Exclusion Criteria

Prophylactic Minimally Invasive Surfactant Evaluation

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome

Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial

Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome

A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)