South Tees NHS Foundation Trust
Middlesbrough, United Kingdom
NCT Number: NCT05782569
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.
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Notify Me23 week–34 week
All sexes
Observational
Middlesbrough, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 hours of age
Lung ultrasound scores within the first 3 hours of life to predict the need for 1st Dose of surfactant
South Tees Hospitals NHS Foundation Trust
Other
Serial Lung Ultrasound in Predicting the Need for Surfactant and Respiratory Course in Preterm Infants - Observational Study (SLURP)
Acronym: SLURP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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