A Clinical trial comparing two different nasal breathing supports in very premature infants

Effect of two different CPAP pressures for primary respiratory support in preterm neonates born at gestational age 26 to 30 weeks: An RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024113

Enrollment

164

Registered

2020-03-20

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: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: High PEEP Group: Initiation of CPAP with high PEEP of 8 cm of water as Primary respiratory support in preterm infants of Gestational age 26 to 30 weeks. Control Intervention1: Standard

Eligibility

Inclusion criteria

Inclusion criteria: Premature infants 26 to 30 weeks requiring respiratory support from day 1 initiated on CPAP either at birth or within few hours of birth. Infants will be stratified by gestational age (26-28 weeks, 28-30 weeks)

Exclusion criteria

Exclusion criteria: 1.Infants with a birth weight 2. Infants requiring extensive resuscitation at birth 3.Pneumothorax 4.Shock requiring inotropic support 5.Multi organ dysfunction 6.Encephalopathy 7.Serious congenital anomalies or any serious abdominal, cardiac, or respiratory malformations.

Design outcomes

Primary

Measure	Time frame
CPAP Failure Rate (need for ventilation or need to increase PEEP beyond the assigned range) Timepoint: First week of postnatal age	—

Secondary

Measure	Time frame
Retinopathy of prematurity ( requiring treatment)Timepoint: During NICU Stay or 3 months post discharge;Time to reach full feedsTimepoint: During NICU Stay;All cause Mortality Timepoint: During NICU stay;Bronchopulmonary Dysplasia at 36 weeks Timepoint: At 36 weeks corrected gestational age;Culture Positive SepsisTimepoint: During NICU stay;Duration of invasive ventilation Timepoint: During NICU Stay;Duration of Maximum PEEP Timepoint: During NICU Stay;Duration of non-invasive ventilation (days) Timepoint: During NICU Stay;Duration of oxygen therapyTimepoint: During NICU Stay;During of hospital stayTimepoint: At the time of discharge;Intraventricular hemorrhage(grade 3 or 4)Timepoint: During NICU stay;Long Term Neurological outcome of the infantTimepoint: At 18 and 24 months of corrected gestational age;Maximum FiO2 RequiredTimepoint: During NICU Stay;Maximum PEEP RequiredTimepoint: During NICU Stay;Nasal injuryTimepoint: During NICU Stay;Necrotizing Enterocilitis( stage 2 or more)Timepoint: During NICU stay;Need for second dose of surfactant Timepoint: During NICU Stay;Need for ventilationTimepoint: During NICU Stay;Patent ductus arteriosus requiring treatmentTimepoint: During NICU stay;Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema)Timepoint: During NICU Stay	—

Measure

Time frame

Retinopathy of prematurity ( requiring treatment)Timepoint: During NICU Stay or 3 months post discharge;Time to reach full feedsTimepoint: During NICU Stay;All cause Mortality Timepoint: During NICU stay;Bronchopulmonary Dysplasia at 36 weeks Timepoint: At 36 weeks corrected gestational age;Culture Positive SepsisTimepoint: During NICU stay;Duration of invasive ventilation Timepoint: During NICU Stay;Duration of Maximum PEEP Timepoint: During NICU Stay;Duration of non-invasive ventilation (days) Timepoint: During NICU Stay;Duration of oxygen therapyTimepoint: During NICU Stay;During of hospital stayTimepoint: At the time of discharge;Intraventricular hemorrhage(grade 3 or 4)Timepoint: During NICU stay;Long Term Neurological outcome of the infantTimepoint: At 18 and 24 months of corrected gestational age;Maximum FiO2 RequiredTimepoint: During NICU Stay;Maximum PEEP RequiredTimepoint: During NICU Stay;Nasal injuryTimepoint: During NICU Stay;Necrotizing Enterocilitis( stage 2 or more)Timepoint: During NICU stay;Need for second dose of surfactant Timepoint: During NICU Stay;Need for ventilationTimepoint: During NICU Stay;Patent ductus arteriosus requiring treatmentTimepoint: During NICU stay;Pulmonary air leaks (pneumothorax, pulmonary interstitial emphysema)Timepoint: During NICU Stay

—

Countries

India

Contacts

Public ContactRicha Choubey

Surya Hospital

nskabra@gmail.com9820919271

Outcome results

None listed

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