Status:
NOT_YET_RECRUITING
Comparison of the Silverman-Andersen Score and the Downes Score
Lead Sponsor:
Muğla Sıtkı Koçman University
Conditions:
Respiratory Distress Neonatal
Noninvasive Ventilation
Eligibility:
All Genders
2-12 years
Brief 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 postna...
Detailed Description
The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation. The study will be conducted in 4 centers (Mugla Training a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07183956
Start Date
September 15 2025
End Date
February 15 2027
Last Update
September 19 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Akdeniz University School of Medicine, Department of Neonatology
Antalya, Antalya, Turkey (Türkiye)
2
Antalya Training and Research Hospital, Department of Neonatology
Antalya, Antalya, Turkey (Türkiye)
3
Mugla Training and Research Hospital, Department of Neonatology
Muğla, Mentese, Turkey (Türkiye), 48000
4
Sanliurfa Training and Research Hospital, Department of Neonatology
Sanliurfa, Şanlıurfa, Turkey (Türkiye)