Oxygen threshold for surfactant administration in preterm neonates

HIGHER (40%) VERSUS CURRENT CONSENSUS (30%) BASED FIO2 THRESHOLD FOR SURFACTANT ADMINISTRATION IN PRETERM NEONATES BETWEEN 26-32 WEEKS OF GESTATIONAL AGE: A NON-INFERIORITY RANDOMIZED CONTROL TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060562

Enrollment

172

Registered

2023-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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 Health Condition 2: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: SURFACTANT ADMINISTRATION AT FIO2 THRESOLD OF 40%: SURFACTANT WILL BE ADMINISTERED IF THE BABIES WILL REQUIRE FIO2 OF 40 PERCENT OR MORE TO MAINTAIN SPO2 BETWEEN 90-95% ON CPAP WITHIN

Eligibility

Inclusion criteria

Inclusion criteria: All must be present 1.Preterm neonates between 26-32 weeks of gestational age 2.Age less than 1 hour 3.Spontaneously breathing with Silverman Andersen score (SAS) =3/10 requiring nasal CPAP at a pressure of 5 cmH2O.

Exclusion criteria

Exclusion criteria: 1.Perinatal Asphyxia (Apgar score 2.Shock requiring inotrope initiation at time of Randomisation 3.Pulmonary hemorrhage at time of Randomisation 4.Major congenital anomaly or chromosomal abnormalities 5.Hydrops fetalis 6.Severe respiratory distress requiring intubation immediately after birth or on admission in NICU

Design outcomes

Primary

Measure	Time frame
To determine the total duration of respiratory support (invasive +non-invasive) in preterm neonates between 26-32 weeks of gestational age with Respiratory Distress Syndrome (RDS) on CPAP in which surfactant will be administered at a FiO2 threshold of 40% as compared to 30%Timepoint: Daily till discharge or death	—

Secondary

Measure	Time frame
1. Requirement of non-invasive positive pressure ventilation, and invasive ventilation within 72 hours after birth 2. Requirement of surfactant within 6 hours after birth 3. Requirement of More than one dose of surfactant 4. Common neonatal morbidities [Bronchopulmonary dysplasia stage = 2 (as per revised NICHD classification, Intraventricular hemorrhage grade (IVH) = grade 2 (as per Volpe’s classification, Retinopathy of prematurity, overall and those requiring treatment as per RBSK guidelines, Air Leak, hsPDA requiring treatment) 5. All-causes Mortality 6. Total duration of hospital stay (in days) Timepoint: Daily till discharge or death	—

Measure

Time frame

1. Requirement of non-invasive positive pressure ventilation, and invasive ventilation within 72 hours after birth 2. Requirement of surfactant within 6 hours after birth 3. Requirement of More than one dose of surfactant 4. Common neonatal morbidities [Bronchopulmonary dysplasia stage = 2 (as per revised NICHD classification, Intraventricular hemorrhage grade (IVH) = grade 2 (as per Volpe’s classification, Retinopathy of prematurity, overall and those requiring treatment as per RBSK guidelines, Air Leak, hsPDA requiring treatment) 5. All-causes Mortality 6. Total duration of hospital stay (in days) Timepoint: Daily till discharge or death

—

Countries

India

Contacts

Public ContactDr Mir Inamul Haq

Lady Hardinge Medical College New Delhi

dr.tapasbanerjee@gmail.com9910371315

Outcome results

None listed

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