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New ultrasound technique could spot heart issues in newborns earlier

NCT ID NCT07364682

Knowledge-focused Sponsor: Birmingham Women's NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests a more sensitive ultrasound method called speckle tracking echocardiography (STE) to check heart function in newborns. Researchers will scan healthy babies and those with conditions like lung disease or oxygen deprivation to establish normal values and track changes during illness. The goal is to help doctors detect heart problems earlier and improve care for sick infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Inpatient status at Birmingham Women's Hospital Neonatal Unit - only babies admitted to the neonatal unit, transitional care ward or postnatal ward will be considered for screening. Belong to one of the following target clinical groups: * Group 1: Term neonates diagnosed with Hypoxic Ischaemic Encephalopathy (HIE) and receiving therapeutic hypothermia. * Group 2: Preterm neonates born at or before 32 weeks' gestation, who are later diagnosed with Chronic Lung Disease (CLD) requiring supplemental oxygen at 36 weeks corrected gestational age. * Group 3: Term neonates diagnosed with Congenital Diaphragmatic Hernia (CDH). * Group 4: Term neonates diagnosed with Acute Pulmonary Hypertension of the Newborn (aPHN), excluding those with CDH. * Healthy controls: * Term neonates (\>36 weeks' gestation) who are well and on postnatal wards. * Well preterm neonates (\<36 weeks' gestation). • Stable enough for echocardiography and research inclusion, as determined by the attending physician.

Ages

0 minutes to 8 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Neonates who are inpatient at the Birmingham Women's Hospital * Confirmed diagnosis of acute pulmonary hypertension, congenital diaphragmatic hernia, hypoxic ischaemic encephalopathy, or bronchopulmonary dysplasia/chronic lung disease (defined by oxygen/respiratory support requirement at 36 weeks post menstrual/corrected gestational age). OR * Health control (\>36 weeks - well and on the postnatal ward) * Well preterm neonate (\<36 weeks) admitted to the NICU, transitional care or post-natal wards. * Informed consent obtained from parent(s) or legal guardian(s) Exclusion Criteria: * Presence of major congenital heart disease (other than patent foramen ovale or patent ductus arteriosus). * Presence of other life-limiting congenital anomalies (other than CDH) or syndromes that could independently affect cardiac function. * Inability to obtain adequate echocardiographic images for STE analysis after reasonable attempts. * If the neonatal consultant or neonatal nurse caring for the neonate feels that the neonate is too unstable for inclusion in the study or that consent should not be sought from parents.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia bronchopulmonary dysplasia chronic obstructive pulmonary disease congenital diaphragmatic hernia perinatal asphyxia persistent fetal circulation syndrome Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lung disease Congenital diaphragmatic hernia Hypoxic ischaemic encephalopathy (HIE) Premature baby Pulmonary hypertension of newborn

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Birmingham Women's Hospital

    Birmingham, B15 2TG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.