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Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants

Nasal intermittent positive pressure ventilation (NIPPV) versus nasal Continuous positive airway pressure (NCPAP) as a primary respiratory support for preterm infants (=34 weeks) – A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065538
Enrollment
160
Registered
2024-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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 intermittent positive pressure ventilation (NIPPV): Preterm (gestational age = 34 weeks)presenting to NICU within 6 hours of birth with Respiratory distress, defined as Silverman

Sponsors

National Institute of Medical Science and Research Jaipur Rajasthan India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates fulfilling all the following criteria 1. Preterm infants (gestational age = 34 weeks) 2. Presenting to NICU within 6 hours of birth 3. Respiratory distress, defined as Silverman Andersen Respiratory Severity Score (SAS score =3/10) 4. Babies whose parents/Guardians have given informed consent

Exclusion criteria

Exclusion criteria: Anyone of the following 1. Major congenital anomaly (antenatally diagnosed or visible at birth) 2. Presence of severe Hemodynamic instability before randomization. [Vasopressor inotrope index = 10 that is dopamine (= 10 mcg/kg/min), dobutamine (= 10 mcg/kg/min), epinephrine (= 0.1 mcg/kg/min), norepinephrine (= 0.1 mcg/kg/min), vasopressin (= 0.001 IU/kg/min) and milrinone (= 0.1 mcg/kg/min)] 3. Baby intubated at or before admission to NICU

Design outcomes

Primary

MeasureTime frame
To assess the need for intubation within the first 72 hours after randomization (within 6 hours after birth) in preterm infants(= 34 weeks) with respiratory distress receiving either NIPPV or CPAP. Timepoint: Discharge from hospital or death—

Secondary

MeasureTime frame
1. Need for surfactant 2. Proportion of neonates requiring mechanical ventilation 3. Proportion of neonates requiring non invasive ventilation. 4. Duration of primary respiratory support. 5. Duration of mechanical ventilation. 6. Duration of non invasive ventilation 7. Duration of oxygen therapy 8. Incidence of sepsis 9. Incidence of air leak 10. Incidence of Pulmonary Hemorrhage 11. Incidence of BPD, HsPDA, IVH Grade 3 or more, NEC, ROP 12. Time to reach full feeds 13. Duration of hospital stay 14. All cause mortalityTimepoint: DISCHARGE OR DEATH—

Countries

India

Contacts

Public ContactGunjana Kumar

National Institute of Medical Science and Research, Jaipur, Rajasthan

gunjanakumar@gmail.com7073077130

Outcome results

None listed

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