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Clinical Trials in Turkey / NCT07183956
Starting soon Observational

Comparison of the Silverman-Andersen Score and the Downes Score

NCT07183956 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-09-15
Last updated
2025-09-19

Condition(s) studied

Respiratory Distress NeonatalNoninvasive VentilationIntubationScoring Systems

Study summary

This study aimed to compare the Silverman-Andersen score and the Downes score in predicting noninvasive ventilation (NIPPV) failure in preterm and term infants who received NIPPV support due to postnatal respiratory distress, as well as to evaluate the agreement of these scoring systems with other methods used to assess the severity of respiratory distress.

The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation.

Eligibility

Sex
ALL
Min age
2 Hours
Max age
12 Hours
Healthy volunteers
No
Inclusion Criteria: * Preterm infants born at \>28 weeks of gestation or term infants born at ≥37 weeks of gestation. * Development of respiratory distress within the first 6 hours after birth, defined as the presence of at least two of the following: Respiratory rate ≥60/min, Subcostal/intercostal retractions, Grunting. * Persistence of respiratory distress for more than 6 hours. * Age within the first 12 hours of life. * Silverman-Andersen score ≥3. * Receiving NIPPV support. Exclusion Criteria: * Major congenital malformations. * Airway or pulmonary anomalies. * Cardiovascular or respiratory instability due to sepsis. * Cyanotic congenital heart disease. * Severe intraventricular hemorrhage. * Contraindications for NIPPV therapy (e.g., congenital nasal anomalies, congenital diaphragmatic hernia, abdominal wall defects). * Requirement of intubation or chest compressions in the delivery room. * Requirement of intubation within the first hour of life. * Death within the first 24 hours of life. * Gestational age ≤28 weeks. * Diagnosis of air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Akdeniz University School of Medicine, Department of Neonatology Antalya Antalya
Antalya Training and Research Hospital, Department of Neonatology Antalya Antalya
Mugla Training and Research Hospital, Department of Neonatology Muğla Mentese
Sanliurfa Training and Research Hospital, Department of Neonatology Sanliurfa Şanlıurfa

More Muğla Sıtkı Koçman University trials in Turkey

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07183956 on ClinicalTrials.gov ↗ ← All trials in Turkey