Premature BirthNCT03199898
Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
An observational study of Premature Birth, run by St. Olavs Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 2 to 2 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Silverman-Andersen Retraction Score
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 30 Jun 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants born <35 weeks of gestational age. the included infants will be stratified in 3 gestational age groups.
Who may be able to join
- born <35 weeks gestational age
Who cannot join
- need of muscle relaxation
- hemodynamic instability
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Premature Birth
- Being tested
- Silverman-Andersen Retraction Score
- Keywords
- Lung/Growth & Development, Respiration, artificial, Reproducibility of Results, Observer Variation
- Medical subject headings
- Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silverman-Andersen Retraction ScoreDiagnostic test
Also called SAs
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Silverman-Andersen Retraction Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
inter-rater reliability of Silverman-Andersen Retraction Score
observers will be pediatric physicians and nurses experienced in the newborn intensive care unit (NICU)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start30 Jun 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Elisabeth Selvaag, md, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199898
- Sponsor's protocol ID
- 2017/588
- Status last verified
- Jul 2019
- First submitted
- 22 Jun 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37390074
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Testing of Silverman-Andersen Retraction Score in Preterm Infants
- ClinicalTrials.gov ID
- NCT03199898
- Acronym / sponsor ID
- 2017/588
- Conditions
- Premature Birth
- Keywords
- Lung/Growth & Development, Respiration, artificial, Reproducibility of Results, Observer Variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Nord-Trøndelag HF
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 34-32 GA | – | Diagnostic Test: Silverman-Andersen Retraction Scorepremature 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. |
| 32-28 GA | – | Diagnostic Test: Silverman-Andersen Retraction Scorepremature 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. |
| 28-23 GA | – | Diagnostic Test: Silverman-Andersen Retraction Scorepremature 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. |
Who may qualify
- Ages
- 2 to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants born <35 weeks of gestational age. the included infants will be stratified in 3 gestational age groups.
Key inclusion criteria (1 listed)
- born <35 weeks gestational age
Key exclusion criteria (2 listed)
- need of muscle relaxation
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silverman-Andersen Retraction ScoreAlso: SAsThe 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). | Diagnostic test | 28-23 GA, 32-28 GA, 34-32 GA |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 37390074Brenne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Selvaag, md study director
St. Olavs Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by St. Olavs Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inter-rater reliability of Silverman-Andersen Retraction Score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.