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Modified Less Invasive Surfactant Administration versus Endotracheal Instillation Followed by Limited Positive Pressure Ventilation in Extremely Premature Infants:A Randomized Controlled Trial in China

Modified Less Invasive Surfactant Administration versus Endotracheal Instillation Followed by Limited Positive Pressure Ventilation in Extremely Premature Infants:A Randomized Controlled Trial in China

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020970
Enrollment
Unknown
Registered
2019-01-23
Start date
2019-02-04
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

neonatal respiratory distress syndrome

Interventions

LISA group:surfactant administration by LISA
Low pressure support group:surfactant administration by low pressure

Sponsors

Women's Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. 25+0 weeks to 31+6 weeks gestational age with 600g-1500g birth body weight; 2. toleranted with non-invasive respiratory support; 3. within 6 hours after birth; 4. indicated to receive surfactant; 5. signed informed content by parents.

Exclusion criteria

Exclusion criteria: 1. need intubation before trial; 2. obvious congenital malformations or chromosomal diseases; 3. neuromuscular diseases affecting respiratory function; 4. Congenital pulmonary infection or pulmonary dysplasia.

Design outcomes

Primary

MeasureTime frame
Mortality at 36 weeks of corrected gestational age;Incidence and extent of bronchopulmonary dysplasia;

Secondary

MeasureTime frame
vital signs during procedure;operation failure;mobidity of associated diseasesduring hospitalizatio;respiratory mode after surfactant administration;

Countries

China

Contacts

Public ContactJiajunzhu ZHU

Women's Hospital, School of Medicine, Zhejiang University

jiajunzhu@zju.edu.cn+86 13858089111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026