NCT07364682Not yet recruiting
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
This study aims to improve how neonatologists check the heart function of newborn babies, especially those who are sick. While standard heart ultrasound scans are useful, a more advanced and sensitive technique called 2D speckle tracking echocardiography (STE) can detect subtle problems with how the heart muscle squeezes and relaxes. This may allow doctors to spot potential issues earlier. Our research will take place at Birmingham Women's Hospital. The investigators will perform these advanced, non-invasive heart scans on several groups of babies: 1. Healthy term and premature babies, to establish a "normal" range of heart function. 2. Babies who are unwell with specific conditions, including those with brain injury due to lack of oxygen at birth (HIE), chronic lung disease of prematurity (BPD), a hole in the diaphragm (CDH), or high blood pressure in their lungs (aPHN). The heart scan is a standard, painless procedure. Using STE does not require any extra scanning time or cause any additional discomfort to the baby; the special images are taken during the routine scan. For many of the sick babies, these scans are already part of their normal clinical care. The main goals of this observational study are to see if STE is a feasible and reliable tool in newborns, to establish normal values for healthy babies, and to track how heart function changes in sick babies during their illness and recovery. Ultimately, the investigators hope this research will provide doctors with a better tool to assess heart health in newborns. This could lead to earlier, more accurate detection of heart problems and help guide treatment decisions to improve outcomes for these vulnerable infants.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 190 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- NCT number
- NCT07364682
What you commit to
- Study type: Observational
- Planned participants: 190
- From 1 Sept 2026 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 0 Minutes to 8 weeks · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Birmingham Women's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.