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EFFECT OF SURFACTANT IN the CINETIC AND INFLAMMATION IN the NEW-BORN PRETERM WHIT RDS SINDROM. - ND

EFFECT OF SURFACTANT IN the CINETIC AND INFLAMMATION IN the NEW-BORN PRETERM WHIT RDS SINDROM. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003224-31-IT
Enrollment
Unknown
Registered
2008-06-10
Start date
2008-03-10
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

PREMATURY NEWBORN WITH WEIGTH = OR < TO 1250g IN ARTIFICIAL VENTILATION MedDRA version: 9.1 Level: LLT Classification code 10038692 Term: Respiratory distress syndrome in newborn

Interventions

Product Name: SURFACTANT Pharmaceutical Form: Endotracheopulmonary instillation, suspension INN or Proposed INN: SURFACTANT Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal

Sponsors

AZIENDA OSPEDALIERA DI PADOVA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)NEW-BORN IN MECCANIC VENTILATION. 2)WEIGHT=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: NEWBORN WHIT CONGENIT DISEASE: ASPHYWIA IA< OR = 3-5 MINUTES NEUROLOGIC DISFUNTIONS: CONVULSIONS, COMA, HYPOTONY ONE OR MORE DISEASE: CARDIVASCULAR, GASTROINTESTINAL,HEMATOLOGIC, LUNS OR KIDNEY DISEASE

Design outcomes

Primary

MeasureTime frame
Main Objective: STUDY OF NEW-BORN WHITH RDS,THE INFLAMATION OF LUNG.;Secondary Objective: CORRELATION THE INFLAMATORY INDEX WHITH CINETIC OF SURFACTANT.;Primary end point(s): VALUTATION OF CINETYC OF SURFACTANT AND INFLAMATION OF LUNG TEXUTE.—

Countries

Italy

Outcome results

None listed

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