SLURP: Serial Lung Ultrasound Predicting Need for Surfactant and Respiratory Course in Preterm Infants Observational Study

Sponsor
South Tees Hospitals NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05782569
Collaborator
(none)
50
10.4

Study Details

Study Description

Brief Summary

Babies born early (under 34 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed (lung immaturity). One of the important components not yet produced by the lungs is the surfactant, which allows premature babies to breathe without much effort. Very often babies born early need some help with their breathing and also need surfactant. Surfactant is administered through a breathing tube which is placed into the baby's airway. It is important that surfactant is administered early after birth when the baby cannot produce it. Early administration of surfactant provides better clinical outcomes.

Currently the decision to give surfactant is based on clinical parameters such as the level of oxygen that your baby requires. Current strategy of waiting for the baby to reach certain oxygen level, may delay in administering surfactant. But recent scientific data from other countries suggest that ultrasound of the chest/lungs can predict early which babies would need surfactant. This would help us to administer surfactant earlier and improve their respiratory outcome. In this study, we want to confirm the value of chest/Lung ultrasound (LU) to predict the need for surfactant in UK population. As a part of the study, we will perform early LU and serial LU in the first few days of life. In this current study, LU images will only be recorded and not used for clinical management.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participant group for the study: Babies born under 34 weeks with a risk of developing lung problems after birth.

    This study is an observational study to confirm the value of chest/Lung ultrasound (LU) to predict the need for surfactant in UK newborn population. As a part of the study, the investigators will perform early LU and serial LU in the first few days of life.

    The investigators will perform the first LU within 3 hours of admission. A Second LU will then be taken at 3-6 hours after surfactant administration (if the baby receives surfactant) or at 6-12 hours of life (if the baby continues to be on Non-invasive respiratory support). A third LU is then taken on Day 2 (12-24 hours after the second LU) and a fourth LU on Day 3 (12-24 hours after the third LU). Then the investigators will carry out additional clinical data collection at hospital discharge.

    Ultrasound is a common procedure carried out in newborn population. The scan should not take more than 3 to 5 minutes. All other data would be obtained from patient notes and databases.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Serial Lung Ultrasound in Predicting the Need for Surfactant and Respiratory Course in Preterm Infants - Observational Study (SLURP)
    Anticipated Study Start Date :
    Mar 20, 2023
    Anticipated Primary Completion Date :
    Jan 31, 2024
    Anticipated Study Completion Date :
    Jan 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Value of chest/Lung ultrasound (LU) to predict the need for surfactant in preterm population. [3 hours of age]

      Lung ultrasound scores within the first 3 hours of life to predict the need for 1st Dose of surfactant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Weeks to 34 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Gestational age ≤34 weeks based on last menstrual period or ultrasound dating.

    2. Non-invasive respiratory support or low flow oxygen needing neonatal unit admission

    Exclusion Criteria:
    1. Received surfactant before first LU (<3hrs of life).

    2. Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.

    3. Infants receiving delivery room surfactant or required intubation shortly after admission.

    4. Infants diagnosed with pneumothorax needing needle or chest tube drainage

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • South Tees Hospitals NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    South Tees Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05782569
    Other Study ID Numbers:
    • PRENET 2297
    First Posted:
    Mar 23, 2023
    Last Update Posted:
    Mar 23, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by South Tees Hospitals NHS Foundation Trust

    Study Results

    No Results Posted as of Mar 23, 2023