our study will try to determine the difference efficacy two different oxygen levels as starting point to administer a drug to reduce respiratory distress in premature babies who are already on non invasive respiratory support

Comparison of efficacy between 35 percent versus 30 percent inspired oxygen fraction threshold with non invasive ventilation (NIPPV) as respiratory support for surfactant administration in respiratory distress syndrome among preterm infants by Less Invasive Surfactant Administration (LISA) technique A non-inferiority trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098332

Enrollment

256

Registered

2025-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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: 35 percent as FiO2 threshold for surfactant administration: In this group, 35 percent FiO2 will be be taken as threshold for surfactant administration by LISA (less invasive surfactant

Eligibility

Inclusion criteria

Inclusion criteria: intramural Preterm babies with gestational age between 24 to 34 weeks diagnosed with RDS and eligible for surfactant administration by the LISA technique will be enrolled in this study RDS will be diagnosed clinically initially and later confirmed by chest X-ray.

Exclusion criteria

Exclusion criteria: Baby with major congenital anomaly , Perinatal asphyxia (Cord blood pH less than 7.0, APGAR score less than 3 for more than 5 minutes, signs of neurological dysfunction and evidence of multiple organ dysfunction), Intubated at the delivery room, An alternative cause of respiratory distress, Any baby requiring mechanical ventilation and surfactant administration

Design outcomes

Primary

Measure	Time frame
Requirement of intubationTimepoint: Within day 3 of life	—

Secondary

Measure	Time frame
Complications occurring during the procedure (Surfactant reflux during the procedure, SpO2 less than 85 percent, hypotension with mean below GA, bradycardia less than 80 bpm, nasal haemorrhage), Need for the second dose of Surfactant, Duration of respiratory support (invasive and non-invasive), Pulmonary hemorrhage, Pulmonary air leak syndromes, Hemodynamically significant PDA requiring treatment, Grade 3 and grade 4 IVH, Periventricular Leukomalacia(PVL), ROP requiring Laser treatment, NEC stage 2 and above, Duration of hospital stay, Bronchopulmonary dysplasia (BPD) Death before hospital dischargeTimepoint: throughout the hospital stay	—

Measure

Time frame

Complications occurring during the procedure (Surfactant reflux during the procedure, SpO2 less than 85 percent, hypotension with mean below GA, bradycardia less than 80 bpm, nasal haemorrhage), Need for the second dose of Surfactant, Duration of respiratory support (invasive and non-invasive), Pulmonary hemorrhage, Pulmonary air leak syndromes, Hemodynamically significant PDA requiring treatment, Grade 3 and grade 4 IVH, Periventricular Leukomalacia(PVL), ROP requiring Laser treatment, NEC stage 2 and above, Duration of hospital stay, Bronchopulmonary dysplasia (BPD) Death before hospital dischargeTimepoint: throughout the hospital stay

—

Countries

India

Contacts

Public ContactBIJAN SAHA

Institute of Post Graduate Medical Education and Research

bijansaha18@gmail.com9051389120

Outcome results

None listed

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