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Comparison Of Non Invasive Ventilation In CPAP Failure Preterm Infants With Respiratory Distress As A Rescue Mode

"Non-Invasive High-Frequency Oscillatory Ventilation Versus Non-Invasive Intermittent Mandatory Ventilation As A Rescue Mode In Preterm Infants With Respiratory Distress On Nasal CPAP- Randomized Trial."

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037681
Enrollment
96
Registered
2021-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: Nasal High- Frequency Oscillatory Ventilation: Nasal High Frequency Oscillatory Ventilation(nHFOV) will be generated by neonatal ventilators (SLE 6000, Acutronic) using nasal prongs or

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants born before 34 weeks gestational age and having respiratory distress before 6 hours of life and requiring nasal CPAP for their management

Exclusion criteria

Exclusion criteria: 1. Neonate with major congenital anamolies 2. Hydrops 3. Systemic signs of shock requiring inotropic support ( >2 inotropes or >10mcg/kg/min of any inotrope) 4. IVH >grade 2 5. Cystic PVL > grade 2 6. Poor respiratory efforts/ encephalopathy 7. Tension Pneumothorax- requiring ICD insertion 8. Critical congenital heart disease

Design outcomes

Primary

MeasureTime frame
To compare the proportion of preterm infants with respiratory distress requiring mechanical ventilation in the first 7 days of life when nasal HFOV is used as rescue mode alternative to NIMV for CPAP failures.Timepoint: 7days—

Secondary

MeasureTime frame
1.Mortality- Death before discharge 2.Respiratory morbidities a. Requirement of Mechanical ventilation in first 72hrs of life b. Duration of non-invasive respiratory support c. Duration of invasive ventilation d. Total duration of respiratory support e. Incidence of pneumothorax f. BPD 3.Hemodynamically significant PDA (HSPDA) 4.Necrotizing enterocolitis (NEC)- more than Stage 2A 5.Retinopathy of prematurity (ROP) requiring LASER 6.Intraventricular hemorrhage (IVH) more than Grade2 7.Periventricular leukomalacia (PVL) more than Grade2 Timepoint: Total duration of NICU stay—

Countries

India

Contacts

Public ContactDr Tejopratap Oleti

FERNANDEZ HOSPITAL, HYDERABAD

tejopratap@gmail.com9989372490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026