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NCT03199898 Clinical Trial

Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

Premature Birth Clinical Trial

Official title:
Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03199898
Other study ID # 2017/588
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2017
Est. completion date April 30, 2019

Study information
Verified date July 2019
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Weeks
Eligibility Inclusion Criteria:

- born <35 weeks gestational age

Exclusion Criteria:

- need of muscle relaxation

- hemodynamic instability

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Norway Levanger Hospital Levanger
Norway St Olavs Hospital Trondheim

Sponsors (3)
Lead Sponsor Collaborator
St. Olavs Hospital Levanger Hospital, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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