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A Partially-Blind, Randomized, Controlled, Parallel-Group Dose Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFactTM (SF-RI 1 surfactant for inhalation combined with a dedicated drug delivery system) in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome

Study category: Infant Care

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Description

Babies in the Active groups may get up to 4 total doses of AeroFact during the first 96 hours of life, depending on how much oxygen and support from the nCPAP/nIMV your baby needs. Re-dosing with drug can occur as frequently as 2 hours after the start of the previous dose. Babies will not receive AeroFact after 4 doses or 96 hours of life. Some babies may need more support than nCPAP/nIMV can provide. Babies in either the Active or Control groups who need more support may be treated with a breathing tube (endotracheal tube) and breathing machine (ventilator), and may receive liquid surfactant through the breathing tube or cannula. Study staff will collect data from the baby’s medical record. This includes information on maternal history, delivery, respiratory support needed, and other complications of prematurity. These details of the baby’s course will be collected until the baby reaches term (40 weeks post-menstrual age, PMA) or NICU discharge, whichever comes first. A breathing questionnaire will be completed at discharge or 40 weeks PMA. Part II of the study begins when the baby is discharged from the hospital, and continues until the baby is 12 months corrected age. This will be done by conducting telephone interviews at 3, 6, 9, and 12 months corrected age. Each call will ask about the baby’s breathing, developmental milestones, and medical issues such as hospitalizations. The goal of these interviews is to assess the effect of AeroFact on longer-term outcomes through the first year of life.

Details
Age

Child

Eligibility

Preterm infants are eligible for this study if they meet all of the following criteria: 1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed) 2. 26 0/7 to 30 6/7 weeks of gestational age 3. Weight < 2000 grams 4. Weight appropriate for gestational age (AGA 3% to 97%) 5. Age less than or equal to twenty-four hours at the initiation of study treatment (active or nCPAP/nIMV alone) 6. Current RSS (MAP x FiO2) 1.4 - 2.0 (nCPAP or nIMV) 7. Chest radiograph consistent with a diagnosis of RDS

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
James Barry,  MD

James Barry, MD

Study ID

Protocol Number: 21-2876

More information available at ClinicalTrials.gov: NCT03969992

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