Two Ways to Help Preterm Babies Breathe: A Study Comparing RAM Cannula and Nasal Mask

Efficacy of RAM Cannula vs Nasal Mask as an Interface in Primary Respiratory Support with Non-Invasive Positive Pressure Ventilation(NIPPV) in Preterm Infants (28 36 weeks GA) with Respiratory Distress A Randomised Controlled Trial - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103767

Enrollment

246

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: J988- Other specified respiratory disorders

Interventions

Intervention1: RAM Cannula: During NIPPV of respiratory support with RAM cannula initial PIP will be at 12 to 14 cm of water and PEEP of 4 to 6 cm of water and fraction of inspired oxygen will be adju

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants born more or equal 28 weeks of gestation 2. Inborn babies up to postnatal age 72 hours 3. Evidence of respiratory distress (SAS Score more than 3)

Exclusion criteria

Exclusion criteria: 1. Babies lesss than 28 weeks of gestational age at birth 2. Outborn babies 3. Major congenital anomalies or known/suspected chromosomal anomalies 4. Upper airway anomalies 5. Severe perinatal asphyxia (blood gas pH less than 7.0 and BE more than-12) 6. Participation in another randomized interventional trial

Design outcomes

Primary

Measure	Time frame
Treatment failureTimepoint: Within 72 hours of life	—

Secondary

Measure	Time frame
1. Bronchopulmonary dysplasia (BPD) 2. Mortality (all causes within NICU stay/ upto 28 days) 3. Invasive ventilator days 4. Invasive Ventilator-free days 5. Necrotizing enterocolitis (Stage 2 and above) 6. Late onset sepsis (only blood culture proven) 7. Gastrointestinal perforation (confirmed on roentgenogram or surgical exploration) 8. Pulmonary air leak, including pulmonary interstitial emphysema (PIE), pneumomediastinum and pneumothorax. 9. Intraventricular haemorrhage on cranial ultrasound, grade 3 and above 10. Feed intolerance Timepoint: Till discharge	—

Measure

Time frame

1. Bronchopulmonary dysplasia (BPD) 2. Mortality (all causes within NICU stay/ upto 28 days) 3. Invasive ventilator days 4. Invasive Ventilator-free days 5. Necrotizing enterocolitis (Stage 2 and above) 6. Late onset sepsis (only blood culture proven) 7. Gastrointestinal perforation (confirmed on roentgenogram or surgical exploration) 8. Pulmonary air leak, including pulmonary interstitial emphysema (PIE), pneumomediastinum and pneumothorax. 9. Intraventricular haemorrhage on cranial ultrasound, grade 3 and above 10. Feed intolerance Timepoint: Till discharge

—

Countries

India

Contacts

Public ContactDr Saugata Chaudhuri

IPGMER and SSKM Hospital

bijansaha18@gmail.com9051389120

Outcome results

None listed

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