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A trial comparing two breathing support machines for premature babies with lung problems

Heated humidified high flow nasal cannula with individualized flow titration (8 12 l/min) versus nasal cpap as primary respiratory support in preterm neonates of 28 36 weeks gestation with respiratory distress syndrome: a pilot randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103763
Enrollment
120
Registered
2026-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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: HHHFNC initiated at 8-10 L/min and titrated up to a maximum of 12 L/min based on gestational age strata.: In the HHHFNC group, flow rate will be initiated as follows: 28 0/7 31 6/7 w

Sponsors

Ankura hospital for women and children kukatpally
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: preterm neonates born at 28 0/7 36 6/7 weeks gestation Diagnosed with RDS based on clinical or radiographic criteria and requiring NRS support.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Composite of receipt of surfactant therapy or treatment failure or requirement of invasive mechanical ventilation (IMV)Timepoint: within 72 hours of life—

Secondary

MeasureTime frame
Treatment failure Timepoint: within 72 hours of life;Requirement of Invasive Mechanical VentilationTimepoint: within 72 hours of life;Receipt of surfactantTimepoint: within 72 hours of life;MortalityTimepoint: until discharge;Bronchopulmonary dysplasia (BPD)Timepoint: at 36 weeks PMA;Mortality or BPDTimepoint: until discharge;Duration of NRS support. Timepoint: until discharge;Air leak syndromes Timepoint: until discharge—

Countries

India

Contacts

Public ContactABDUL KHADER

Ankura hospital for women and children, kukatapally

19.vira@gmail.com8130402185

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026