Status:
UNKNOWN
LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants
Lead Sponsor:
Anhui Provincial Hospital
Collaborating Sponsors:
The First Affiliated Hospital of University of Science and Technology of China
The First Affiliated Hospital of Bengbu Medical University
Conditions:
Preterm Infants
Eligibility:
All Genders
25-32 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of less invasive surfactant administration（LISA ）technique in the treatment of neonatal respiratory distress syndrome（NRDS） by comparing with the traditional Intubate-Surfacta...
Detailed Description
Background: Neonatal Respiratory distress syndrome (NRDS) is the most common cause of respiratory problems in premature babies. Surfactant administration involved with endotracheal intubation and mech...
Eligibility Criteria
Inclusion
- Gestational age (GA) less than 32 weeks
- diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (Progressive dyspnea, nasal flaring and or grunting), chest X-ray findings and need for noninvasive ventilation support(fraction of inspired oxygen\>40％) in 6 hours after birth
- informed parental consent has been obtained
Exclusion
- severe RDS have been treated with endotracheal intubation,surfactant and mechanical ventilation
- major congenital malformations or complex congenital heart disease
- Pulmonary hemorrhage
- Cardiopulmonary failure
- septicemia, Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), and Congenital genetic metabolic disease
- transferred out of the NICUs(neonatal intensive care units) with surgical treatment or other intervention
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04126382
Start Date
January 1 2020
End Date
December 31 2024
Last Update
October 15 2019
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