Comparison of the Silverman-Andersen Score and the Downes Score
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorMuğla Sıtkı Koçman University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Major congenital malformations.
Airway or pulmonary anomalies.
Cardiovascular or respiratory instability due to sepsis.
Cyanotic congenital heart disease.
Trial population
Preterm infants born at \>28 weeks of gestation and term infants born at ≥37 weeks of gestation who developed respiratory distress within the first 6 hours after birth.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
220 Participants
are grouped into 1 trial groupGroup A: Infants >28 weeks GA treated with NIPPV due to respiratory distress within the first 12 h of life
Trial outcomes
Primary outcomes
1
To determine the predictive role of the Silverman-Andersen score for noninvasive ventilation failure at 24 and 72 hours of life.
Noninvasive ventilation failure will be defined as the need for intubation in an infant receiving NIPPV. The Silverman-Andersen score will be assessed at 30 minutes after initiation of NIPPV therapy, and its predictive value for noninvasive ventilation failure will be evaluated at 24 and 72 hours of life. The Silverman-Andersen score assesses upper chest movement, intercostal retractions, subxiphoid retractions, nasal flaring, and air entry to the lungs on auscultation. Each parameter is scored between 0 and 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater severity of respiratory distress (5).
Time frame
24 hours and 72 hours after birth2
To determine the predictive role of the Downes score for noninvasive ventilation failure at 24 and 72 hours of life
Noninvasive ventilation failure will be defined as the need for intubation in an infant receiving NIPPV. The Downes score will be assessed at 30 minutes after initiation of NIPPV therapy, and its predictive value for noninvasive ventilation failure will be evaluated at 24 and 72 hours of life. The Downes score evaluates cyanosis, respiratory rate, retractions, grunting, and air entry to the lungs on auscultation. Each parameter is scored between 0 and 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater severity of respiratory distress (5).
Time frame
24 hours and 72 hours after birthSecondary outcomes
1
Agreement of the Respiratory Severity Score with the Silverman-Andersen score and Downes score
Respiratory Severity Score will be calculated as FiO₂ × MAP (mean airway pressure) (references: 6, 7).
Time frame
30 minutes after the initiation of NIPPV therapy2
Agreement of the oxygen saturation index (OSI) with the Silverman-Andersen score and Downes score
Oxygen saturation index (OSI) will be calculated following formula: \[MAP (cmH₂O) × FiO₂ (%)\] / SpO₂ (%)\] (references: 6, 7).
Time frame
30 minutes after the initiation of NIPPV therapy3
Agreement of the blood gas pH and PaCO₂ with the Silverman-Andersen score and Downes score
The investigators routinely perform blood gas evaluations after birth in infants with respiratory distress.
Time frame
30 minutes after the initiation of NIPPV therapy4
Agreement of the SpO₂/FiO₂ ratio with the Silverman-Andersen score and Downes score
In infants with respiratory distress, the investigators monitor SpO₂ using a bedside monitor after birth and record FiO₂ levels on the ventilator used for noninvasive ventilation follow-up
Time frame
30 minutes after the initiation of NIPPV therapySponsors and contacts
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Source ClinicalTrials.gov
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