Status:
WITHDRAWN
nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
Lead Sponsor:
Indus Hospital and Health Network
Conditions:
Respiratory Distress Syndrome in Premature Infant
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief Summary
Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Non...
Detailed Description
Respiratory distress is a common morbidity in preterm neonates that requires respiratory support and surfactant replacement, if not adequately and timely managed may cause multi-organ dysfunction. Res...
Eligibility Criteria
Inclusion
- Inborn Preterm Neonates 26-34 weeks gestation admitted to NICU with diagnosis of RDS
- Babies who were initially started on High Flow Oxygen Therapy/nCPAP but unable to maintain saturation \> 90% on fio2 of 40% in 1st 6 hours of life.
- Capillary PCO2 of \> 70 or arterial PCO2 \> 65 on two repeated sampling within 4 hours
- Neonates whose parents consented to participate.
Exclusion
- All preterm babies who are below \< 26 weeks above the 34 weeks of gestation
- Preterm neonates (26-34 weeks) with diagnosis of RDS requiring endotracheal intubation within Labor room/Operation Theater or within 1st hour of life for respiratory support.
- Preterm Neonates with the gestational age of 26-34 weeks, diagnosed as congenital pneumonia or sepsis.
- Patient with poor respiratory drive due to any reason neurological or central causes
- Diaphragmatic hernia or any other thoracic anomaly
- Pleural effusion unilateral or bilateral
- Congenital cystic pulmonary malformation.
- Neonates with underlying cyanotic heart disease.
- Neonates with acynotic heart disease causing pulmonary edema
- Neonates with cleft lip and cleft palate or any other surgical condition.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04914715
Start Date
June 30 2021
End Date
December 30 2023
Last Update
March 12 2024
Active Locations (1)
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1
Indus Hospital and Health Network
Karachi, Sindh, Pakistan, 75190