To compare the efficacy of better fraction of inspired oxygen at thirty percent or 40 percent for administering surfactant in preterm babies with respiratory distress syndrome

Early surfactant administration at two different fractions of inspired oxygen thresholds: 40 percentage vs 30 percentage; in preterm neonates 26 to 34 weeks of gestation with respiratory distress syndrome on nCPAP: An open labelled randomized controlled trial - OpFiTS trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088512

Enrollment

120

Registered

2025-06-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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: Group A: Neonates will receive surfactant if the FiO2 requirement within 2hrs is more than equal to 40 % to maintain preductal spO2 levels 91% to 95%. If FiO2 requirement is less than 4

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates 26 0/7 to 33 6/7 weeks of gestation with respiratory distress syndrome requiring FiO2 of more than equal to 30% or of more than equal to 40% on nCPAP/NIV as the initial mode of respiratory support within 2hours of birth admitted to the NICU.

Exclusion criteria

Exclusion criteria: 1 Neonates requiring intubation in the delivery room or within two hours after birth 2 Life threatening congenital malformations 3 Other causes of respiratory distress other than RDS 4 APGAR less than 5 at 5min or cord gas pH less than 7 or base deficit of morethan equal to 16

Design outcomes

Primary

Measure	Time frame
Proportion(%) of infants requiring intubation & mechanical ventilation in the first 72hrs of lifeTimepoint: First 72hrs of life	—

Secondary

Measure	Time frame
10. Length of hospitalization in daysTimepoint: During NICU stay;1. Proportion of infants with death and BPD at 36 weeks of PMATimepoint: at 36 weeks PMA ;2. Duration of invasive ventilation support & oxygen supportTimepoint: During NICU stay;3. Duration of CPAP supportTimepoint: During NICU stay;4. Post surfactant CPAP settings PEEP and FiO2Timepoint: 12hrs after surfactant instillation;5. Median time to receive surfactantTimepoint: 72hrs of life;6. Total number of surfactant doses receivedTimepoint: 72hrs of life;7. Oxygenation index, ratio of spO2 and FiO2, AaDo2 at day 3 of lifeTimepoint: Day 3 of life;8. Morbidities- late onset sepsis, hs-PDA, severe IVH (grade =2), PVL (grade =2), severe ROP (stage2), severe NEC (=stage 2a)Timepoint: During NICU stay;9. Proportion of infants with air leaks, pneumothorax, pulmonary interstitial emphysemaTimepoint: During NICU stay	—

Measure

Time frame

10. Length of hospitalization in daysTimepoint: During NICU stay;1. Proportion of infants with death and BPD at 36 weeks of PMATimepoint: at 36 weeks PMA ;2. Duration of invasive ventilation support & oxygen supportTimepoint: During NICU stay;3. Duration of CPAP supportTimepoint: During NICU stay;4. Post surfactant CPAP settings PEEP and FiO2Timepoint: 12hrs after surfactant instillation;5. Median time to receive surfactantTimepoint: 72hrs of life;6. Total number of surfactant doses receivedTimepoint: 72hrs of life;7. Oxygenation index, ratio of spO2 and FiO2, AaDo2 at day 3 of lifeTimepoint: Day 3 of life;8. Morbidities- late onset sepsis, hs-PDA, severe IVH (grade =2), PVL (grade =2), severe ROP (stage2), severe NEC (=stage 2a)Timepoint: During NICU stay;9. Proportion of infants with air leaks, pneumothorax, pulmonary interstitial emphysemaTimepoint: During NICU stay

—

Countries

India

Contacts

Public ContactDr Phalguni Padhi

AIIMS Raipur

phalguni2011@gmail.com9040632169

Outcome results

None listed

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