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Single-blind randomized clinical trial in premature infants with Respiratory Distress Syndrome (RDS) eligible for treatment with exogenous surfactant identified early by lung ultrasonography.

Phase 1
Conditions
Premature infants with Respiratory Distress Syndrome (RDS)
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Registration Number
CTIS2024-515641-42-00
Lead Sponsor
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Premature newborns of both sexes, between 24 and 32 weeks and/or = 1500 grams at birth, who do not meet any of the exclusion criteria, will be included.

Exclusion Criteria

Lack of parental informed consent., Patients presenting with any of the following conditions: • Chromosomal abnormalities or complex congenital malformations., Patients presenting with any of the following conditions: Congenital lung diseases., Patients presenting with any of the following conditions: Severe sepsis or septic shock., Patients presenting with any of the following conditions: Meconium aspiration syndrome., Patients presenting with any of the following conditions: Administration of surfactant in the delivery room.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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