Status:
UNKNOWN
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
Lead Sponsor:
University of Arizona
Conditions:
Infant, Extremely Premature
Acute Lung Injury
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehi...
Detailed Description
In extremely premature infants who are ventilated there is ongoing lung injury \& lung inflammation. This can perpetuate the need for ongoing ventilation and these infants spend much longer in the hos...
Eligibility Criteria
Inclusion
- Infants born at \< 30+0/7 weeks (23+0 - 29+6/7) gestational age (GA) OR with preterm infants with a birth weight (BW) which is \< 1500 gm AND if they have severe respiratory distress syndrome (RDS) (Clinical diagnosis based on the need for mechanical ventilation in preterm infant or if they have radiologic features of RDS along with need for positive distending airway pressure and fractional inspired oxygen (FiO2) \> 0.3)
Exclusion
- major congenital defects
- chromosomal abnormality
- pneumothorax
- Known surgical disease
- Known or suspected congenital heart disease
- Infant not considered viable by physician
- Severe sepsis / infections
- Likely to be extubated within the next 24 hours
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05364385
Start Date
December 2 2019
End Date
December 1 2024
Last Update
November 1 2022
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85719