Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

Depending on their gestational age, preterm infants need several weeks with different types of breathing-support due to immature development of the lungs, respiratory muscles, chest-wall and respiratory center in the brain. WHO's recommendation on interventions to improve preterm birth outcomes underline the need for more research on respiratory support in infants born preterm. This study will test inter-rater and intra-rater reliability of the Silverman-Andersen Retraction Score, which is a systematic clinical scoring tool for the respiratory work and the severity of respiratory distress in preterm infants. It will examine if there is consistency in the assessments done by doctors and nurses, and also if the observations correlate with technological monitoring. This easy to use scoring tool will help to determine the grade of respiratory distress, to assess respiratory exacerbation, to decide when to start weaning from respiratory support, and to give the best respiratory treatment to the child. This study will contribute to optimize care for preterm infants with respiratory distress.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Diagnostic test: Silverman-Andersen Retraction Score

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Norway
  • Levanger, Norway
    • Levanger Hospital
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature infants born <35 weeks of gestational age. the included infants will be stratified in 3 gestational age groups.

Description

Inclusion Criteria:

• born <35 weeks gestational age

Exclusion Criteria:

• need of muscle relaxation
• hemodynamic instability

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
34-32 GA; premature infants born <34,6-32,1 weeks of gestational age (GA) receiving different types of non-invasive and invasive respiratory support, and severity of respiratory distress assessed by Silverman-Andersen Retraction Score.	Diagnostic test: Silverman-Andersen Retraction Score; The Silverman-Andersen Retraction Score (SAs) is used to assess severity of respiratory distress in newborn and preterm infants without respiratory support.The score comprises 4 inspiratory categories of movements (thoraco-abdominal, intercostal, xiphoid, and chin movements) and one expiratory category (grunting).; Other Names: SAs
32-28 GA; premature infants born <32-28,1 weeks of gestational age (GA) receiving different types of non-invasive and invasive respiratory support, and severity of respiratory distress assessed by Silverman-Andersen Retraction Score.	Diagnostic test: Silverman-Andersen Retraction Score; The Silverman-Andersen Retraction Score (SAs) is used to assess severity of respiratory distress in newborn and preterm infants without respiratory support.The score comprises 4 inspiratory categories of movements (thoraco-abdominal, intercostal, xiphoid, and chin movements) and one expiratory category (grunting).; Other Names: SAs
28-23 GA; premature infants born <28-23,0 weeks of gestational age (GA) receiving different types of non-invasive and invasive respiratory support, and severity of respiratory distress assessed by Silverman-Andersen Retraction Score.	Diagnostic test: Silverman-Andersen Retraction Score; The Silverman-Andersen Retraction Score (SAs) is used to assess severity of respiratory distress in newborn and preterm infants without respiratory support.The score comprises 4 inspiratory categories of movements (thoraco-abdominal, intercostal, xiphoid, and chin movements) and one expiratory category (grunting).; Other Names: SAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inter-rater reliability of Silverman-Andersen Retraction Score	observers will be pediatric physicians and nurses experienced in the newborn intensive care unit (NICU)	2 weeks

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology; Helse Nord-Trøndelag HF
• Investigators: Study Director: Elisabeth Selvaag, md, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 24, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Reproducibility of Results; Respiration, artificial; Lung/Growth & Development; Observer Variation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2017/588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No