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CompletedNCT03199898Updated Feb 17, 2020

Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

An observational study in Premature Birth, sponsored by St. Olavs Hospital. Completed at 2 sites in Norway. Open to participants aged 2 Weeks to 2 Weeks. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by St. Olavs Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
40
Ages
2 Weeks to 2 Weeks
Sex
All
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Study 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.

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Conditions studied

  • Premature Birth

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Keywords

  • Lung/Growth & Development
  • Respiration, artificial
  • Reproducibility of Results
  • Observer Variation
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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 40 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Weeks to 2 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • born \<35 weeks gestational age

Exclusion criteria

Exclusion Criteria:

  • need of muscle relaxation
  • hemodynamic instability
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testSilverman-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).

    Also known as: SAs

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What researchers measure

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)

    Time frame: 2 weeks

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Study locations

2 sites
  • Levanger Hospital
    Levanger, Norway
  • St Olavs Hospital
    Trondheim, Norway
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03199898
Lead sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Nord-Trøndelag HF
Responsible party
Sponsor
First posted
Jun 27, 2017
Start date
Jun 30, 2017
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019
Last update
Feb 17, 2020

Study contacts

Elisabeth Selvaag, md
study director · St. Olavs Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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