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Completed

NCT Number: NCT03058666

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

USA Children's & Women's Hospital, Mobile, Alabama, United States

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About this study

Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

RDS Patients

  • NICU patient, ≥1hour of age and <24 hours of age.
  • Clinical diagnosis of RDS, with or without chest X-ray data.
  • Inspired oxygen ≥21% to maintain adequate oxygen saturation.
  • Not intubated
  • Requiring:
  • nasal continuous positive airway pressure (nCPAP).

Exclusion criteria

  • Congenital anomaly limiting care options or requiring early surgery.
  • Cardiopulmonary decompensation.
  • hypotension with metabolic acidosis (base excess < -10 meq/l).
  • Oxygen saturations < 88% at start of aerosolization.
  • PaCO2 ≥ 60 mmHg at start of aerosolization.
  • Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
  • Acute hypoxic encephalopathy with or without seizures.

Treatment and study plan

Aerosolized Calfactant

Drug

Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Other names: Infasurf, Calfactant

Solarys

Device

Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Primary outcomes

  1. Intubation and Instillation of Liquid Surfactant

    Time frame: 72 hours

    Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Secondary outcomes

  1. Respiratory Support Requirements

    Time frame: 28 days

    Difference of Respiratory support at 28 days

  2. Air Leak

    Time frame: 28 days

    Percent of at risk subjects with air leak at any time

Sponsors and collaborators

Lead sponsor

ONY

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
May 29, 2024

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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