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Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

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ClinicalTrials.gov Identifier: NCT03199898
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Levanger Hospital
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment
Premature Birth Diagnostic Test: Silverman-Andersen Retraction Score

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

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 Name: 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 Name: 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 Name: SAs




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • born <35 weeks gestational age

Exclusion Criteria:

  • need of muscle relaxation
  • hemodynamic instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199898


Locations
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Norway
Levanger Hospital
Levanger, Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Levanger Hospital
Investigators
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Study Director: Petter Aadahl, md prof St. Olavs Hospital

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03199898     History of Changes
Other Study ID Numbers: 2017/588
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Lung/Growth & Development
Respiration, artificial
Reproducibility of Results
Observer Variation
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications