Comparison of the Silverman-Andersen Score and the Downes Score
NCT ID: NCT07183956
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
220 participants
OBSERVATIONAL
2025-09-15
2027-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
NCT03199898
Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room
NCT03166826
Non-invasive Ventilation
NCT07186790
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
NCT01861795
Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score
NCT05617989
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants:
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 (defined as the presence of at least two of the following: respiratory rate ≥60/min, subcostal/intercostal retractions, and grunting), whose respiratory distress persisted for more than 6 hours, who were within the first 12 hours of life, had a Silverman-Andersen score ≥3, and received NIPPV support will be included in the study (1).
Infants with 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 (such as congenital nasal anomalies, congenital diaphragmatic hernia, or abdominal wall defects), those who required intubation or chest compressions in the delivery room, required intubation within the first hour of life, died within the first 24 hours of life, were born at ≤28 weeks of gestation, or were diagnosed with air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy will be excluded from the study.
Respiratory support protocol Infants ≥34 weeks of gestation with respiratory distress within the first 6 hours of life will be observed for 2 hours; if distress persists and the Silverman-Andersen score is ≥3, NIPPV will be initiated. Infants \<34 weeks with respiratory distress and a Silverman-Andersen score ≥3 will be directly started on NIPPV. NIPPV is a routine, noninvasive respiratory support modality widely used in our unit and globally. Ventilatory support will be delivered via short binasal prongs using a mechanical ventilator.
Initial NIPPV settings will be: PIP 15-20 cmH₂O, PEEP 5-6 cmH₂O, rate 40-50 breaths/min, inspiratory time (Ti) 0.35-0.45 s, and flow 8-10 L/min. PIP may be increased by 1-2 cmH₂O increments up to a maximum of 25 cmH₂O if required. FiO₂ will be titrated to maintain oxygen saturation between 90-94%.
Assessment of respiratory severity Silverman-Andersen and Downes scores will be assessed 20-30 minutes after initiation of NIPPV using standardized scoring systems. Blood gas analysis will be performed within 30 minutes after NIPPV initiation. Additional indices of respiratory severity-including the respiratory severity score (RSS), FiO₂, mean airway pressure (MAP), and oxygen saturation index (OSI)-will be recorded at 20-30 minutes. RSS will be calculated as FiO₂ × MAP; MAP as \[(Ti × PIP) + (Te × PEEP)\] / (Ti + Te); and OSI as \[MAP (cmH₂O) × FiO₂ (%)\] / SpO₂ (%)\] (18, 19). All scoring and calculations will be performed by a pediatrician, neonatology fellow, or neonatologist, each trained in standardized assessment prior to the study.
Definition of NIPPV failure and success NIPPV failure will be defined as the presence of severe respiratory acidosis (pH \<7.20, PaCO₂ \>60 mmHg), oxygen saturation \<90% despite FiO₂ \>50%, \>3 apnea episodes within 1 hour, \>2 apnea episodes requiring positive pressure ventilation with a bag-valve-mask device within 24 hours, or shock requiring inotropic support. Infants with NIPPV failure will be intubated and managed with conventional mechanical ventilation. Infants extubated within 1 hour following ENSURE (ENtubation, SURfactant, Extubation) will not be considered NIPPV failures, whereas those remaining intubated for \>1 hour after ENSURE will be classified as failures.
Weaning from NIPPV will be attempted when PIP is reduced to 14-15 cmH₂O, PEEP to 5 cmH₂O, respiratory rate to 20-30/min, and FiO₂ \<30%, provided that the Silverman-Andersen score is \<3 and both clinical findings and blood gas parameters are acceptable. Infants successfully weaned from NIPPV will be considered to have achieved NIPPV success.
Surfactant and caffeine therapy Surfactant therapy is routinely performed in our unit and is not a novel intervention. Surfactant will be administered at a dose of 200 mg/kg via either LISA (Less Invasive Surfactant Administration) or ENSURE when FiO₂ ≥40% is required to maintain target oxygen saturation of 90-94%. In preterm infants with RDS who require intubation for respiratory failure, surfactant will be administered via an endotracheal tube (2). A second dose will be given if FiO₂ requirement persists at ≥40%. All infants born before 32 weeks of gestation or with a birth weight \<1500 g will routinely receive prophylactic caffeine therapy as standard practice.
Study parameters and outcomes The following parameters will be compared between infants with and without NIPPV failure: Silverman-Andersen score, Downes score, respiratory severity score, oxygen saturation index, SpO₂/FiO₂ ratio, duration of NIPPV, surfactant requirement, mortality, blood gas parameters, and demographic characteristics.
The primary outcome is to determine the most appropriate scoring system for predicting noninvasive ventilation failure by comparing the predictive performance of the Silverman-Andersen and Downes scores within the first 24 and 72 hours of life. The secondary outcome is to assess the correlation of both scores with duration of noninvasive ventilation, SpO₂/FiO₂ ratio, oxygen saturation index, respiratory severity score, and blood gas parameters (pH and PaCO₂), and to determine which scoring system demonstrates stronger correlation. Additionally, the predictive value of both scores for mortality and surfactant requirement in infants born before 34 weeks of gestation will be compared.
Sample size calculation Previous studies have shown that initiating respiratory support with NIPPV in infants with respiratory distress reduces the incidence of respiratory failure and the need for intubation compared to NCPAP (3). Permatahati et al. (4) reported an NCPAP failure rate of 37% when applied as primary respiratory support in preterm infants with respiratory distress. In the present study, the investigators hypothesized that the NIPPV failure rate would decrease from 37% to 20% when NIPPV is used as the primary respiratory support in neonates with respiratory distress. Based on this hypothesis, a power analysis was performed using G\*Power version 3.1.9.4, with a type I error of 5% and 80% power, resulting in a required sample size of 220 patients.
Statistical analysis:
Data will be analyzed using the SPSS statistical software. Descriptive statistics will be presented as percentages (%), means, or medians, as appropriate. The Kolmogorov-Smirnov, Shapiro-Wilk, skewness, and kurtosis tests will be used to assess the normality of the data. Comparisons between infants with and without NIPPV failure will be performed using the Student's t-test, Mann-Whitney U test, and chi-square test, as appropriate.
Receiver operating characteristic (ROC) curve analysis will be used to calculate the area under the curve (AUC), sensitivity, and specificity of the Silverman-Andersen and Downes scores for predicting NIPPV failure. Comparisons of AUC values will be performed using MedCalc software. Optimal cut-off values for both scores in predicting NIPPV failure will be determined using the maximum Youden index.
Pearson and Spearman correlation analyses will be used to assess the relationship between the Silverman-Andersen and Downes scores and other respiratory distress parameters, including respiratory severity score, oxygen saturation index, blood gas pH and PaCO₂, and SpO₂/FiO₂ ratio. A p-value \<0.05 will be considered statistically significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infants >28 weeks GA treated with NIPPV due to respiratory distress within the first 12 h of life
Infants born at \>28 weeks of gestation who develop respiratory distress within the first 6 h of life and receive noninvasive ventilation therapy (NIPPV) within the first 12 h will be included in the study. Silverman-Andersen and Downes scores will be assessed 20-30 minutes after initiation of NIPPV using standardized scoring systems. Blood gas analysis will be performed within 30 minutes after NIPPV initiation. Additional indices of respiratory severity-including the respiratory severity score (RSS), FiO₂, mean airway pressure (MAP), and oxygen saturation index (OSI)-will be recorded at 20-30 minutes. RSS will be calculated as FiO₂ × MAP; MAP as \[(Ti × PIP) + (Te × PEEP)\] / (Ti + Te); and OSI as \[MAP (cmH₂O) × FiO₂ (%)\] / SpO₂ (%)\] (18, 19). NIPPV failure will be defined as the need for intubation in an infant receiving NIPPV. In the same infants, the predictive value of the Silverman-Andersen score and the Downes score for NIPPV failure at 24 hours and 72 hours will be evaluated.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
2 Hours
12 Hours
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Muğla Sıtkı Koçman University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ozkan Ilhan
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ozkan Ilhan
Role: STUDY_DIRECTOR
Mugla Training and Research Hospital
Ozkan Ilhan, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Mugla Sitki Kocman University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akdeniz University School of Medicine, Department of Neonatology
Antalya, Antalya, Turkey (Türkiye)
Antalya Training and Research Hospital, Department of Neonatology
Antalya, Antalya, Turkey (Türkiye)
Mugla Training and Research Hospital, Department of Neonatology
Muğla, Mentese, Turkey (Türkiye)
Sanliurfa Training and Research Hospital, Department of Neonatology
Sanliurfa, Şanlıurfa, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Iyer NP, Mhanna MJ. Non-invasively derived respiratory severity score and oxygenation index in ventilated newborn infants. Pediatr Pulmonol. 2013 Apr;48(4):364-9. doi: 10.1002/ppul.22607. Epub 2013 Jan 28.
Muniraman HK, Song AY, Ramanathan R, Fletcher KL, Kibe R, Ding L, Lakshmanan A, Biniwale M. Evaluation of Oxygen Saturation Index Compared With Oxygenation Index in Neonates With Hypoxemic Respiratory Failure. JAMA Netw Open. 2019 Mar 1;2(3):e191179. doi: 10.1001/jamanetworkopen.2019.1179.
Abdallah Y, Mkony M, Noorani M, Moshiro R, Bakari M, Manji K. CPAP failure in the management of preterm neonates with respiratory distress syndrome where surfactant is scarce. A prospective observational study. BMC Pediatr. 2023 May 3;23(1):211. doi: 10.1186/s12887-023-04038-6.
Permatahati WI, Setyati A, Haksari EL. Predictor Factors of Continuous Positive Airway Pressure Failure in Preterm Infants with Respiratory Distress. Glob Pediatr Health. 2021 Apr 7;8:2333794X211007464. doi: 10.1177/2333794X211007464. eCollection 2021.
Lemyre B, Deguise MO, Benson P, Kirpalani H, Ekhaguere OA, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD005384. doi: 10.1002/14651858.CD005384.pub3.
Ozkan H, Erdeve O, Kutman HGK. Turkish Neonatal Society guideline on the management of respiratory distress syndrome and surfactant treatment. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S45-S54. doi: 10.5152/TurkPediatriArs.2018.01806. eCollection 2018.
1. Report of National Neonatal perinatal Database (NNPD) 2002-2003. Available from http://www.newbornwhocc.org/nnpo_html. Accessed Dec 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MSKU-NICU-OI-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.