Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants

NCT ID: NCT03199898

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-30

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Silverman-Andersen Retraction Score

Intervention Type 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).

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.

Silverman-Andersen Retraction Score

Intervention Type 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).

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.

Silverman-Andersen Retraction Score

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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SAs

Eligibility Criteria

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Inclusion Criteria

* born \<35 weeks gestational age

Exclusion Criteria

* need of muscle relaxation
* hemodynamic instability
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Selvaag, md

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

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Levanger Hospital

Levanger, , Norway

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 37390074 (View on PubMed)

Other Identifiers

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2017/588

Identifier Type: -

Identifier Source: org_study_id

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