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Does rotation of nasal interfaces decreases the incidence of nasal injury in neonates on nasal CPAP

Does rotation of nasal interfaces decreases the incidence of nasal injury in neonates on nasal CPAP: A randomized control trial - NICOPAP TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017320
Enrollment
195
Registered
2019-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: ROTATION GROUP: PRETERM NEONATES IN THIS GROUP WILL RECIEVE CPAP BY ALTERNATE ROTATION OF NASAL MASK AND NASAL PRONG EVERY 8 HOURLY Control Intervention1: NASAL PRONG GROUP: PRETERM NEO

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Inborn preterm neonates of 2.Neonates intubated in the delivery room for asphyxia or for surfactant administration and extubated to CPAP within 6 hours of life will be also eligible. 3.Inborn/outborn preterm neonates <35 weeks of gestation requiring CPAP/ NIMV as post-extubation respiratory support.

Exclusion criteria

Exclusion criteria: 1. Perinatal asphyxia (5 minute Apgar score of =3) 2. Life threatening congenital malformations such as congenital diaphragmatic hernia, trachea-esophageal fistula 3. Malformations that would prevent establishing CPAP such as Pierre-Robinson syndrome, choanal atresia, cleft lip and palate 4. Major congenital abnormality including antenatally diagnosed chromosomal abnormalities 5. Conditions where CPAP would be contraindicated such as • Poor spontaneous respiratory efforts or apnea • Worsening shock • Suspected or proven PPHN • Severe metabolic acidosis (pH -10), • Severe respiratory acidosis (pH 55mmHg) • Massive pulmonary hemorrhage

Design outcomes

Primary

MeasureTime frame
Incidence and severity of nasal injury at removal of CPAP based on the objective scoringTimepoint: TILL THE END OF CPAP—

Secondary

MeasureTime frame
a.The need for mechanical ventilation. b.The duration of CPAP. c.Incidence of bronchopulmonary dysplasia (BPD) d.Intraventricular haemorrhages (IVH) in neonates less than 1.5 kg birth weight. e.Periventricular leucomalacia (PVL) in neonates less than 1.5 kg birth weight. f.Mortality among the groups will be noted till the baby is in NICU.Timepoint: TILL THE END OF CPAP—

Countries

India

Contacts

Public ContactDr Gaurav Gautam

AIIMS, Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

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