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

NCT05782569 | Unknown

• 1 other identifier: PRENET 2297
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant, Premature

Keywords

Babies born under 34 weeks; Risk of developing lung problems after birth

Outcome Measures

Primary Outcomes (1)

• 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

  3 hours of age

Eligibility Criteria

• Age: 23 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead

Related Publications (1)

• Loganathan PK, Meau-Petit V, Bhojnagarwala B, Nair V, Holmes J, Occhipinti A, Montasser M. Serial lung ultrasound in predicting the need for surfactant and respiratory course in preterm infants-multicentre observational study (SLURP). Eur J Pediatr. 2025 May 23;184(6):356. doi: 10.1007/s00431-025-06185-7.

  PMID: 40407825 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Jane Greenaway

CONTACT

01642850850; tvra.projects@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: March 23, 2023
• Study Start: March 20, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-02