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A study comparing two ways of giving surfactant to preterm babies with breathing difficulty.

Efficacy of Surfactant administration through Laryngeal Mask Airway (LMA) vs Less Invasive Surfactant Administration (LISA) in Preterm Neonates. - LMA , LISA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099879
Enrollment
60
Registered
2025-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Interventions

Intervention1: LMA Group: Preterm neonates with respiratory distress syndrome requiring surfactant therapy will receive surfactant administration through a Laryngeal Mask Airway (LMA). The procedure w

Sponsors

Pt Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants between 30 to 34+6 weeks of gestation who develop mild to moderate respiratory distress between 4 to 48 hours of birth, requiring FiO2 0.3 to 0.60 to maintain SpO2 88 to 95 percent on nCPAP of 5to 6 cm of H2O and signed the parental consent.

Exclusion criteria

Exclusion criteria: Previous intubation or Surfactant therapy. Apgar score of greater than or equal to 3 at 5 min. Pneumothorax prior to enrolment. Severe RDS indicated by FiO2 greater than 0.60. Newborns with major congenital anomalies (major malformations involving craniofacial, Cardiac or thoracic). Newborns with perinatal asphyxia.

Design outcomes

Primary

MeasureTime frame
Need for mechanical ventilation within 72 hours of surfactant administrationTimepoint: Within 3 Days

Secondary

MeasureTime frame
Duration of hospital stay Intraventricular haemorrhage (IVH) Neonatal Necrotizing Enterocolitis Mortality Timepoint: Untill discharge or death.

Countries

India

Contacts

Public ContactApurva Negi

Pt. Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana

apurvagomar@gmail.com8544731551

Outcome results

None listed

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