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Comparison of Efficacy of three types of non-invasive respiratory supports after removal of endotracheal tube in preterm & term neonates.

Efficacy of Nasal high frequency oscillatory ventilation (nHFOV) VERSUS Synchronised non-invasive positive pressure ventilation (SNIPPV) VERSUS Nonsynchronised non-invasive positive pressure ventilation (NS-NIPPV) as a post extubation respiratory support in preterm neonates (ââ?°Â¥ 28 WEEKS OF GESTATION) admitted in a tertiary care centre ââ?¬â?? A 3 ARM RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073484
Enrollment
129
Registered
2024-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: J969- Respiratory failure, unspecified

Interventions

Intervention1: Nasal high frequency oscillatory ventilation (nHFOV): After randomization Nasal high frequency oscillatory ventilation (nHFOV) will be used for 72 hours after extubation. Control Interv

Sponsors

Neonatology Departmental Fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants born �28 weeks of gestation 2. Inborn babies upto postnatal age 15 days 3. Mechanically ventilated for at least 12 hrs.

Exclusion criteria

Exclusion criteria: 1. Infant born at less than 28 weeks of gestational age 2. Outborn babies 3. Major congenital anomalies or suspected chromosomal anomalies 4. Upper airway malformations 5. Severe perinatal asphyxia

Design outcomes

Primary

MeasureTime frame
Extubation failure within 72 hoursTimepoint: Extubation failure within 72 hours—

Secondary

MeasureTime frame
1. Bronchopulmonary dysplasia (BPD) 2. Mortality (all causes within NICU stay/ upto 28 days) 3. Invasive ventilator days 4. Invasive Ventilator free days 5. Necrotizing enterocolitis (Stage 2 and above)35 6. Late onset sepsis (only blood culture proven) 7. Gastrointestinal perforation (confirmed on roentgenogram or surgical exploration) 8. Pulmonary air leak including pulmonary interstitial emphysema (PIE), pneumomediastinum and pneumothorax. 9. Intraventricular haemorrhage on cranial ultrasound, grade 3 and above 10. Feed intolerance 11. Retinopathy of prematurity (ROP) any stage Timepoint: upto discharge or death—

Countries

India

Contacts

Public ContactSk samim

IPGMER & SSKM Hospital

bijansaha18@gmail.com9051389120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026