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Completed

NCT Number: NCT02294630

Aerosolized Surfactant in Neonatal RDS

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.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Surfactant

Drug

Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.

Other names: Survanta

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Feasibility

    Time frame: During and within 6 hours after end of study drug administration, expected maximum of approximately 14 hours

    Since surfactant reflux is typically considered to be one of the most likely adverse events associated with the intervention, it was planned to report the number of participants specifically with surfactant reflux for this Outcome Measure

  2. Patient Status as Evaluated by Dose Level

    Time frame: During study drug administration, expected maximum of approximately 8 hours for adverse effects and infant comfort; need for intubation was assessed within 72 hours of study intervention.

    Optimal dosing schedule was determined by preliminary evidence of efficacy (Need for intubation within 72 hours), lack of adverse effects, and overall infant comfort as assessed by bedside clinical caregivers.

  3. Short Term Efficacy as Assessed by Need for Intubation

    Time frame: Within 72 hours of study intervention

    It will be suggested that infants be intubated and receive MV if they met 2 or more of 5 failure criteria: i). worsening clinical signs of respiratory distress (increasing tachypnea; expiratory grunting; intercostal, subcostal, and/or sternal recession); ii). apnea treated with positive pressure ventilation (PPV) by mask on 2 or more occasions in 1 hour; iii). FIO2 >0.5 to maintain pulse oxygen saturations 90%-95% for >30 minutes; iv). pH <7.2 on 2 arterial or capillary blood gases taken >30 minutes apart; and v). partial pressure of CO2 (PCO2) of >65 mm Hg on 2 CBG/ABGs taken 30 minutes apart.

Secondary outcomes

  1. Blood Gas Parameters - pH

    Time frame: 60±30 minutes after end of study intervention

    Blood gas pH

  2. Blood Gas Parameters - pCO2

    Time frame: 60±30 minutes after end of study intervention

    Blood gas pCO2.

  3. Pulse Oximetry

    Time frame: 60±30 minutes after end of study intervention

    Transcutaneous Pulse oximetry

  4. Vital Signs - Heart Rate

    Time frame: 60±30 minutes after end of study intervention

    Vital signs included heart rate, respiratory rate and systolic blood pressure

  5. Vital Signs - Respiratory Rate

    Time frame: 60±30 minutes after end of study intervention

    Vital signs included heart rate, respiratory rate and systolic blood pressure

  6. Vital Signs - Systolic Blood Pressure

    Time frame: 60±30 minutes after end of study intervention

    Systolic blood pressure

  7. Number of Doses of Surfactant - Aerosolized & Intratracheal

    Time frame: Within 72 hours of study intervention

  8. Pneumothorax, Pneumomediastinum or Other Air Leak

    Time frame: Within 72 hours of study intervention

  9. Changes in Cerebral Oxygenation From Baseline as Evaluated at End of Study Intervention

    Time frame: During and within 6 hours after end of study intervention, expected maximum of approximately 14 hours

    Changes in cerebral oxygenation from baseline as evaluated at end of study intervention

  10. Changes in Surfactant Activity in Gastric Aspirates

    Time frame: During study intervention, expected maximum of approximately 8 hours

    Concentration of major surfactant lipid (PC 16:0/16:0)

  11. Cumulative Duration of Non-invasive and Invasive Ventilation

    Time frame: at discharge

    Cumulative duration of non-invasive and invasive ventilation at discharge

  12. Duration of Supplemental Oxygen, Intensive Care, Hospital Stay

    Time frame: During initial hospital stay, expected <= 120 days

    Duration of supplemental oxygen, and hospital stay

  13. Age at Start of Feeds, Feeding Progression, Age at Full Enteral Feeds

    Time frame: During initial hospital stay, expected 1st 2 weeks of life

    Age at start of feeds, and age at full enteral feeds presented in days

  14. Need for Blood Transfusions

    Time frame: During initial hospital stay, expected <= 120 days

    Number of infants requiring blood transfusions

  15. Growth Parameters

    Time frame: At 7 days, 28 days, 36 weeks corrected GA and discharge

    Weight at discharge

  16. Morbidities Associated With Prematurity

    Time frame: During initial hospital stay, expected <= 120 days

    Grade III & IV IVH PDA requiring ligation ROP treated with Laser Surgical NEC BPD

  17. Survival to Hospital Discharge

    Time frame: During initial hospital stay, expected <= 120 days

    Survival to hospital discharge

  18. Survival to Discharge Without Severe Morbidity

    Time frame: During initial hospital stay, expected <= 120 days

    Survival to discharge without severe BPD, severe IVH, surgical NEC or ROP treated with Laser

Sponsors and collaborators

Lead sponsor

Sood, Beena G., MD, MS

Indiv

Registry information

Official study title

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

Acronym: AS-02

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2014
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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