Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia
University of Wisconsin, Madison
Summary
This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
Description
Primary Objective • To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants. Secondary Objectives * To evaluate the oxygenation response to late surfactant therapy with budesonide in extremely preterm infants at 48 hours and 7 days after completion of the study intervention * To evaluate respiratory outcomes following administration of late surfactant therapy with budesonide
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Neonate Inclusion Criteria: * Gestational age 22 0/7 to 28 6/7 weeks at birth * Age 7-14 days * Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3 Birthing Parent Inclusion Criteria: * Have a baby who meets neonate eligibility criteria and enrolls in the study. Neonate Exclusion Criteria: * Major congenital anomalies including congenital lung malformations and congenital diaphragmatic hernia and/or genetic disorders * Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g.…
Interventions
- DrugCalfactant
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
- DrugBudesonide
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
Locations (2)
- Meriter HospitalMadison, Wisconsin
- American Family Children's HospitalMadison, Wisconsin