Outcomes in preterm babies with respiratory distress syndrome when surfactant admnistration at different thershold(fio2-40 percent vs 30 percent)

High (greater than 0.40) versus Low (greater than 0.30) Fractional Inspired Oxygen Threshold for Surfactant Therapy in Preterm Infants with Respiratory Distress Syndrome- A Randomized Controlled Trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075976

Enrollment

128

Registered

2024-10-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: surfactant admisntartion for preterm babies: all preterm babies who developed respiartory distress soon after birth (fitting in inculsion criteria) were started on cpap support if babie

Eligibility

Inclusion criteria

Inclusion criteria: 1) Preterm Infants with gestation less than 36 weeks requiring CPAP respiratory support within 6 hours after birth. 2) Parental consent

Exclusion criteria

Exclusion criteria: 1) Preterm infants requiring directly mechanical ventilation in initial hours after birth. 2) Preterm infants with gestation less than 25 weeks. 3) Infants with major congenital anomalies including nasopharyngeal pathology including cleft palate. 4) Infants who are hemodynamically unstable requiring inotropes

Design outcomes

Primary

Measure	Time frame
To compare the need for mechanical ventilation in the first 72 hrs following surfactant adminstration between 2 groups.Timepoint: From surfactant adminstration to next 72 hrs	—

Secondary

Measure	Time frame
To compare the duration of invasive /non-invasive/oxygen as respiratory support. To compare the incidence of pneumothorax. To compare the incidence of Bronchopulmonary dysplasia Timepoint: From admission to till 12 weeks of life or till discharge, which is earlier	—

Countries

India

Contacts

Public ContactMADINENI VENKAT NAVEEN

IMS AND SUM HOSPITAL,SOA University

debasishnanda@soa.ac.in9861422685

Outcome results

None listed

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