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

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Middlesbrough, United Kingdom
        • South Tees NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 hours of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

June 17, 2024

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infant, Premature

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