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CSASDSSilverman-Andersen and Downes Scores for Neonatal Respiratory Distress

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Dyspnea+10

+ Hyaline Membrane Disease

+ Infant, Newborn, Diseases

+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2025
See protocol details

Summary

Principal SponsorMuğla Sıtkı Koçman University
Study ContactOzkan Ilhan, Associate ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating two different scoring systems, the Silverman-Andersen score and the Downes score, to assess how well they predict the need for more intensive breathing support in newborns experiencing breathing difficulties shortly after birth. Specifically, it looks at preterm infants born after 28 weeks and full-term infants who show signs of respiratory distress within the first six hours of life. These scoring systems help determine the severity of the condition and whether the babies require additional interventions beyond noninvasive ventilation. The potential benefit of this study is to improve early detection of serious respiratory issues and ensure timely, effective treatment, ultimately reducing the number of newborns who need invasive procedures. In the study, the infants are given noninvasive positive pressure ventilation (NIPPV) using short nasal prongs connected to a mechanical ventilator. Medical staff monitor the infants' breathing rates, oxygen levels, and other vital signs. The performance of the Silverman-Andersen and Downes scores is tested by recording these scores shortly after starting NIPPV and comparing them with actual outcomes, like how long the infants need ventilation and whether they eventually require more intensive support. The study also examines other factors, such as blood gas levels and oxygen requirements, to see how well the scores predict the need for further intervention. The goal is to find out which scoring system provides the most accurate early warning of potential ventilation failure, guiding better treatment decisions for these vulnerable infants.

Official TitleComparison of the Silverman-Andersen Score and the Downes Score in Assessing the Severity of Respiratory Distress and Predicting Noninvasive Ventilation Failure in Neonates
NCT07183956
Principal SponsorMuğla Sıtkı Koçman University
Study ContactOzkan Ilhan, Associate ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DyspneaHyaline Membrane DiseaseInfant, Newborn, DiseasesInfant, Premature, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration DisordersRespiratory Distress Syndrome, NewbornRespiratory Distress SyndromeRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
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.

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11 exclusion criteria prevent from participating
Major congenital malformations.

Airway or pulmonary anomalies.

Cardiovascular or respiratory instability due to sepsis.

Cyanotic congenital heart disease.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Akdeniz University School of Medicine, Department of Neonatology

Antalya, Turkey (Türkiye)Open Akdeniz University School of Medicine, Department of Neonatology in Google Maps
Suspended

Antalya Training and Research Hospital, Department of Neonatology

Antalya, Turkey (Türkiye)
Suspended

Mugla Training and Research Hospital, Department of Neonatology

Muğla, Turkey (Türkiye)
Suspended

Sanliurfa Training and Research Hospital, Department of Neonatology

Sanliurfa, Turkey (Türkiye)
Recruiting soon4 Study Centers