Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

NCT03199898 | Completed

• 1 other identifier: 2017/588
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Premature Birth

Keywords

Lung/Growth & Development; Respiration, artificial; Reproducibility of Results; Observer Variation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

Silverman-Andersen Retraction Score DIAGNOSTIC_TEST

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).

Also known as: SAs

28-23 GA; 32-28 GA; 34-32 GA

Eligibility Criteria

• Age: 2 Weeks - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• born \<35 weeks gestational age

You may not qualify if:

• need of muscle relaxation
• hemodynamic instability

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Helse Nord-Trøndelag HF: collaborator

Study Sites (2)

Levanger Hospital

Levanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Brenne H, Follestad T, Bergseng H, Eriksen BH, Soraunet K, Grunewaldt KH. Inter-rater reliability of the Silverman and Andersen index-a measure of respiratory distress in preterm infants. PLoS One. 2023 Jun 30;18(6):e0286655. doi: 10.1371/journal.pone.0286655. eCollection 2023.

  PMID: 37390074 DERIVED

MeSH Terms

Conditions

Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth Selvaag, md

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: June 30, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 17, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)