CPAP vs. No-CPAP: Which is Better for Newborns with Mild Breathing Issues?

No-CPAP versus CPAP in late preterm and term neonates with mild respiratory distress: A non-inferiority parallel group open-label randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073879

Enrollment

212

Registered

2024-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: P221- Transient tachypnea of newborn

Interventions

Intervention1: No-CPAP: Late pre-term (34 weeks 0/7 days to 36 weeks 6/7 days of gestation) and term neonates (37 weeks 0/7 days to 41 weeks 6/7 days of gestation) with mild respiratory distress at bi

Eligibility

Inclusion criteria

Inclusion criteria: Late pre-term (34 weeks,0/7 days to 36 weeks,6/7 days of gestation) and term neonates (37 weeks, 0/7 to 41 weeks 6/7 days of gestation) with mild respiratory distress defined as Silverman-Anderson score of 1-3 at birth

Exclusion criteria

Exclusion criteria: 1.Requirement of positive pressure ventilation for more than 30 seconds at birth 2.Perinatal asphyxia â?? Apgar score of less than 7 at one minute of life 3.Babies born with meconium-stained liquor 4.Maternal chorioamnionitis 5.Suspected or known major congenital malformation or any malformation that interferes with intervention and outcome 6.Requirement of NICU admission for any cause other than transient tachypnea of newborn

Design outcomes

Primary

Measure	Time frame
To determine the duration of respiratory support in late-preterm and term neonates with mild respiratory distress, managed with No-CPAP vs. CPAP in the delivery room at birthTimepoint: From institution to removal of respiratory support	—

Secondary

Measure	Time frame
Need for neonatal intensive care unit (NICU) admissionTimepoint: From randomization to decision for neonatal intensive care unit (NICU) admission;Escalation of respiratory supportTimepoint: From randomization to shifting out of neonatal intensive care unit (NICU);Incidence of air leak e.g. pneumothoraxTimepoint: From randomization to discharge from hospital;Duration of neonatal intensive care unit (NICU) stayTimepoint: Total duration of NICU stay calculated from NICU admission to shifting out of NICU;Duration of hospital stayTimepoint: Total duration of hospital stay calculated from day of birth to the day of hospital discharge	—

Measure

Time frame

Need for neonatal intensive care unit (NICU) admissionTimepoint: From randomization to decision for neonatal intensive care unit (NICU) admission;Escalation of respiratory supportTimepoint: From randomization to shifting out of neonatal intensive care unit (NICU);Incidence of air leak e.g. pneumothoraxTimepoint: From randomization to discharge from hospital;Duration of neonatal intensive care unit (NICU) stayTimepoint: Total duration of NICU stay calculated from NICU admission to shifting out of NICU;Duration of hospital stayTimepoint: Total duration of hospital stay calculated from day of birth to the day of hospital discharge

—

Countries

India

Contacts

Public ContactDr Ritesh Ranjan Saha

AIl India Institute of Medical Sciences, New Delhi

dranuthukral@gmail.com9891392188

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026