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Use of less invasive method in administering surfactant

A comparative study of the effectiveness of administering surfactant by a (LISA) with a standard (invasive) method in premature infants with RDS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230326057775N1
Enrollment
120
Registered
2023-10-09
Start date
2022-08-05
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: In the intervention group, the less invasive method (LISA) is used for surfactant injection, and the endotracheal tube, which is an invasive method, is not used. In

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: All babies with GA = 28-34 weeks Have RDS (respiratory score greater than 5) CPAP pressure > 6 cm H2O

Exclusion criteria

Exclusion criteria: Babies with chromosomal abnormalities Major congenital anomalies Oxygen (FiO2) > 40%

Design outcomes

Primary

MeasureTime frame
The frequency of surfactant injection. Timepoint: Depending on the need for surfactant, every few hours or every few days. Method of measurement: Number of injections.;Time to start supplemental feeding. Timepoint: How many days after birth did the feeding start?. Method of measurement: Day.;Duration of mechanical ventilation. Timepoint: day. Method of measurement: Based on the number of days required for ventilation.

Secondary

MeasureTime frame
Incidence of Retinopathy of prematurity (ROP). Timepoint: Initial screening will be done as soon as possible and followed up for up to 3 months. Method of measurement: Eye examination by a retina specialist.;Incidence of bronchopulmonary dysplasia (BPD). Timepoint: After 28 days, it is checked daily. Method of measurement: Based on oxygen requirement and ventilator dependence.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdieh Saberi Anari

Yazd University of Medical Sciences

dr.mahdiehsaberi@gmail.com+98 35 3183 3734

Outcome results

None listed

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