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comparing surfactant administration techniques: LISA vs InSurE in preterm infants with RDS

COMPARISON OF SURFACTANT ADMINISTRATION TECHNIQUE: LISA VS INSURE IN PRETERM BABIES WITH RESPIRATORY DISTRESS SYNDROME-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039147
Enrollment
150
Registered
2022-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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: LISA method for surfactant administration(Less invasive surfactant administration) technique: surfactant was administered using 5Fr feeding tube to preterm babies with RDS within 6 hour

Sponsors

Government Medical College Aurangabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: spontaneously breathing preterm infants with RDS diagnosed within 24 h of life and meeting two or more criteria for surfactant therapy from 28 weeks 0 days to 36 weeks 6 daysâ?? gestational age.

Exclusion criteria

Exclusion criteria: infants with anatomical abnormalities of upper airway; major congenital anomalies; congenital diaphragmatic hernia; trachea-esophagealfistula; choanal atresia; cleft palate; and poor respiratory efforts. Also, infants requiring intubation and invasive ventilation due to hemodynamic instability or fraction of inspired oxygen (FiO2) requirement 0.6 were excluded.

Design outcomes

Primary

MeasureTime frame
need of mechanical ventilation within 72 hours of birthTimepoint: need of mechanical ventilation within 72 hours of birth

Secondary

MeasureTime frame
Incidence of major complications, length of hospital stay, duration of mechanical ventilation, duration of NIPPV, and survival outcomeTimepoint: till discharge or death

Countries

India

Contacts

Public ContactAradhana Mishra

Government Medical College Aurangabad

nicugmcha@gmail.com09903381947

Outcome results

None listed

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