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NCT Number: NCT05782569

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

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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Key information

Age range

23 week–34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

South Tees NHS Foundation Trust

Middlesbrough, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age ≤34 weeks based on last menstrual period or ultrasound dating.
  • Non-invasive respiratory support or low flow oxygen needing neonatal unit admission

Exclusion criteria

  • Received surfactant before first LU (<3hrs of life).
  • Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.
  • Infants receiving delivery room surfactant or required intubation shortly after admission.
  • Infants diagnosed with pneumothorax needing needle or chest tube drainage

Treatment and study plan

Primary outcomes

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

    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

Sponsors and collaborators

Lead sponsor

South Tees Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Serial Lung Ultrasound in Predicting the Need for Surfactant and Respiratory Course in Preterm Infants - Observational Study (SLURP)

Acronym: SLURP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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