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Comparison of Minimally Invasive Surfactant Administration (LISA) and Endotracheal Intubation-Surfactant-Extubation (INSURE) in Preterm Infants Receiving Calf Pulmonary Surfactant Therapy: A Multicenter, Prospective, Real-World, Comparative Effectiveness Study

Comparison of Minimally Invasive Surfactant Administration (LISA) and Endotracheal Intubation-Surfactant-Extubation (INSURE) in Preterm Infants Receiving Calf Pulmonary Surfactant Therapy: A Multicenter, Prospective, Real-World, Comparative Effectiveness Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100088
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-04-02
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Preterm infants

Interventions

INSURE treatment group:None
LISA treatment group:None

Sponsors

International Peace Maternity & Child Health Hospital of China welfare institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preterm infants with gestational age of 25-32 weeks; 2. Continuous non-invasive assisted breathing in the delivery room and during transfer to the neonatal intensive care unit after birth, and no invasive mechanical ventilation was performed at the time of recruitment; 3. Have a clinical indication for pulmonary surfactant therapy, meet one of the following conditions: nasal continuous positive airway pressure (nCPAP) pressure >=6cmH2O, inspired oxygen concentration (FiO2) >0.30, imaging confirmed respiratory distress syndrome (RDS) or rapid disease progression, requiring mechanical ventilation; 4. It is proposed to use LISA or INSURE technology to give surfactant treatment to bovine lung; 5. The child's guardian agrees to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Severe congenital malformations; 2. Severe cyanotic congenital heart disease affecting systemic hemodynamics; 3. Congenital hereditary metabolic diseases; 4. Respiratory distress caused by meconium aspiration; 5. Severe infection.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse composite outcomes;

Secondary

MeasureTime frame
In-hospital mortality;Incidence of bronchopulmonary dysplasia;72-hour invasive mechanical ventilation rate;Total 1-week invasive mechanical ventilation time;Total duration of invasive mechanical ventilation during hospitalization;Duration of assisted ventilation;Secondary drug administration rate;Days of hospitalization;Blood gas indicators;Neonatal complication rate;Duration of oxygen therapy;

Countries

China

Contacts

Public ContactZhiwei Liu

International Peace Maternity and Child Health Hospital of China Welfare Institution

liuzhiwei@hotmail.com+86 21 6407 0434

Outcome results

None listed

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