An observational study in Infant, Premature, sponsored by South Tees Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 23 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by South Tees Hospitals NHS Foundation Trust · Observational
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.
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 86 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →South Tees Hospitals NHS Foundation Trust is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Recruiting the neonatal (Newborn) population. Currently there is no definite way of identifying which infant would need surfactant so this research would study study the value of lung ultrasound in predicting which infant would benefit from surfactant
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Exclusion Criteria:
Value of chest/Lung ultrasound (LU) to predict the need for surfactant in preterm population.
Lung ultrasound scores within the first 3 hours of life to predict the need for 1st Dose of surfactant
Time frame: 3 hours of age
Ran from May 2023 to primary completion in Jun 2024, 13 months.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's 13 months is below that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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South Tees Hospitals NHS Foundation Trust