Respiratory Distress Syndrome in Premature Infant Clinical Trial
— IPVOfficial title:
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
Verified date | January 2024 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the benefits and safety of Intrapulmonary Percussive Ventilation in preterm infants. IPV has been demonstrated to be safe, and improve airway secretions clearance and decreased atelectasis in pediatric patients. We aim to evaluate the effects of IPV in preterm infants.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Days and older |
Eligibility | INCLUSION CRITERIA - Premature infants born before 32 weeks of gestation with birth weight less than 1500 grams. - Infants requiring positive pressure ventilation by 14 days of life. EXCLUSION CRITERIA - Infants with known or suspected chromosomal anomalies (Trisomy 13, 18, 21) - Infants with Congenital Diaphragmatic Hernia - Presence of air leak syndrome (pneumothorax, pneumomediastinum) - Previous diagnosis of air leak syndrome. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mechanical ventilation and supplemental oxygen | Need for mechanical ventilation and supplemental oxygen administration | From the date of starting treatment protocol to 2 weeks after. | |
Secondary | Diagnosis of Bronchopulmonary Dysplasia | Need for mechanical ventilation and supplemental oxygen administration | At 36 weeks gestational age |
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