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Completed

NCT Number: NCT03199898

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.

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Key information

Age range

2 week–2 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Levanger Hospital, Levanger, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • born <35 weeks gestational age

Exclusion criteria

  • need of muscle relaxation
  • hemodynamic instability

Treatment and study plan

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).

Other names: SAs

Primary outcomes

  1. inter-rater reliability of Silverman-Andersen Retraction Score

    Time frame: 2 weeks

    observers will be pediatric physicians and nurses experienced in the newborn intensive care unit (NICU)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Helse Nord-Trøndelag HF
  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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