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Application of continuous air pressure through nose on lungs versus high oxygen flow in prematurely born babies as breathing support.

Heated humidified high flow nasal cannula versus nasal continuous positive airway pressure as a primary mode of respiratory support in preterm babies between 30+0 - 33+6 weeks. A randomised controlled trial - HiPAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056392
Enrollment
60
Registered
2023-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J989- Respiratory disorder, unspecified

Interventions

Intervention1: heated humidified high flow nasal cannula(HHHFNC): heated humidified high flow nasal cannula as a primary respiratory support within first 6 hours of birth in mild to moderate respirato

Sponsors

IMS and SUM hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants are eligible for the study if they match the following inclusion criteria: 1. GA of 30+0wks to 33+6 wks. 2. Mild to moderate RDS requiring NIV support, characterized by Silverman Anderson score of 3 or higher or fio2 >0.21 to maintain a target saturation of 91% to 95%.

Exclusion criteria

Exclusion criteria: Infants are considered ineligible if they present with the following : 1. Severe RDS requiring early intubation according to American academy of pediatrics guidelines for neonatal resuscitation. 2. Major congenital anomalies that might affect respiratory outcomes. 3. Nasopharyngeal pathology including cleft palate. 4. Antenatal diagnosis of Congenital heart disease. 5. Severe intraventricular hemorrhage.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of HHHFNC when compared to nasal CPAP as a primary source of respiratory support in preterm babies.Timepoint: 0 days 3 days 7 days—

Secondary

MeasureTime frame
Secondary outcome :length of stay, duration of respiratory support, incidence of BPD, NEC, sepsis, mortality, time to reach full feeds (120ml), discharge weight are the secondary outcomes.Timepoint: 0 days , 3 days , 7 days—

Countries

India

Contacts

Public ContactAshish Ragireddy

IMS & SUM hospital

drabhilipsa40@gmail.com9818936828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026