Comparison of two modes of surfactant delivery (minimally invasive and conventional) in preterm newborns suffering from respiratory distress syndrome

Comparison of safety and efficacy of minimally invasive surfactant therapy with surfactant administration through endotracheal tube (InSurE) in preterm newborns with respiratory distress syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053907

Enrollment

628

Registered

2023-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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: MIST: Newborns suffering from RDS will receive surfactant by Minimally invasive surfactant therapy. Control Intervention1: InSurE: Newborns of this group will receive surfactant by conv

Eligibility

Inclusion criteria

Inclusion criteria: Newborns suffering from respiratory distress syndrome

Exclusion criteria

Exclusion criteria: Major congenital anomaly, severe birth asphyxia, refusal of consent

Design outcomes

Primary

Measure	Time frame
Need of mechanical ventilation (invasive)Timepoint: Till hospital discharge	—

Secondary

Measure	Time frame
BPDTimepoint: First 30 days of life;IVHTimepoint: First 30 days of life;NECTimepoint: First 30 days of life;ROPTimepoint: First 30 days of life	—

Countries

India

Contacts

Public ContactKamirul Islam

Burdwan Medical College

drmainak95@gmail.com

Outcome results

None listed

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