Comparison of the Silverman-Andersen Score and the Downes Score

NCT07183956 | Not Yet Recruiting

• 1 other identifier: MSKU-NICU-OI-02
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Respiratory Distress Neonatal; Noninvasive Ventilation; Intubation; Scoring Systems

Keywords

Silverman-Andersen score; Downes score; Newborn; Respiratory distress; Noninvasive ventilation

Outcome Measures

Primary Outcomes (2)

• 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).

  24 hours and 72 hours after birth

• 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).

  24 hours and 72 hours after birth

Secondary Outcomes (6)

• Agreement of the Respiratory Severity Score with the Silverman-Andersen score and Downes score

  30 minutes after the initiation of NIPPV therapy

• Agreement of the oxygen saturation index (OSI) with the Silverman-Andersen score and Downes score

  30 minutes after the initiation of NIPPV therapy

• Agreement of the blood gas pH and PaCO₂ with the Silverman-Andersen score and Downes score

  30 minutes after the initiation of NIPPV therapy

• Agreement of the SpO₂/FiO₂ ratio with the Silverman-Andersen score and Downes score

  30 minutes after the initiation of NIPPV therapy

• The predictive value of Silverman-Andersen score and Downes score for surfactant requirement in infants born before 34 weeks of gestation

  At 48 hours following the initiation of NIPPV therapy

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Hours - 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (4)

Akdeniz University School of Medicine, Department of Neonatology

Antalya, Antalya, Turkey (Türkiye)

Location

Antalya Training and Research Hospital, Department of Neonatology

Antalya, Antalya, Turkey (Türkiye)

Location

Mugla Training and Research Hospital, Department of Neonatology

Muğla, Mentese, 48000, Turkey (Türkiye)

Location

Sanliurfa Training and Research Hospital, Department of Neonatology

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 23359457 BACKGROUND

• 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.

  PMID: 30924897 BACKGROUND

• 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.

  PMID: 37138252 BACKGROUND

• 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.

  PMID: 33889679 BACKGROUND

• 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.

  PMID: 37466143 BACKGROUND

• 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.

  PMID: 31236018 BACKGROUND

• 1. Report of National Neonatal perinatal Database (NNPD) 2002-2003. Available from http://www.newbornwhocc.org/nnpo_html. Accessed Dec 2014.

  BACKGROUND

MeSH Terms

Conditions

Hyaline Membrane Disease; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ozkan Ilhan

  Mugla Training and Research Hospital

  STUDY DIRECTOR

• Ozkan Ilhan, Assoc. Prof.

  Mugla Sitki Kocman University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozkan Ilhan, Associate Professor

CONTACT

+90 506 293 4400; drozkanilhan@gmail.com

Ipek Kocaoglu, Dr.

CONTACT

+90 530 516 5187; ipekkc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)