Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography

NCT07364682 | Not Yet Recruiting

• 1 other identifier: 25/BW/OGN/NO/984
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Healthy term and premature babies, to establish a "normal" range of heart function.
2. 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).

Conditions

Pulmonary Hypertension of Newborn; Hypoxic Ischaemic Encephalopathy (HIE); Congenital Diaphragmatic Hernia; Chronic Lung DIsease; Premature Baby

Keywords

Speckle Tracking Echocardiography; STE; Functional echocardiography; Neonatal Performed Echocardiography

Outcome Measures

Primary Outcomes (3)

• To assess the feasibility of acquiring adequate quality images for comprehensive Right ventricular - Speckle Tracking Echocardiography (RV-STE), Left ventricular (LV) STE, and left atrial (LA) -STE in neonates with aPHN, CDH, HIE, and BPD.

  Feasibility rate of RV, LV, and LA STE.

  By completion of data collection (September 2027)

• To describe the longitudinal changes in RV, LV, and LA STE parameters from acute illness through recovery/discharge in each disease cohort.

  The invetigators will measure this by looking at values and longitudinal trends of: RV-Global Longitudinal Strain (GLS), RV-Free Wall Longitudinal Strain (FWLS), LV-GLS, LA reservoir strain (LASr) in healthy neonates and neonates with disease conditions (HIE, BPD, CDH, aPHN).

  By September 2027

• To establish normative values of simultaneously performed RV, LV and LA strain in well term and preterm neonates

  The investigators will establish normative reference RV, LV and LA strain using two-dimensional speckle-tracking echocardiography in a cohort of well term and preterm neonates. Report Strain values as means ± standard deviations and percentiles (5th-95th), stratified by gestational age, postnatal age, and birth weight categories.

  By September 2027

Secondary Outcomes (3)

• To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements

  By September 2027

• To compare STE-derived parameters with conventional echocardiographic measures of cardiac function.

  By September 2027

• To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate

  By September 2027

Study Arms (6)

Congenital Diaphragmatic Hernia

Term neonates diagnosed with Congenital Diaphragmatic Hernia (CDH)

Hypoxic Ischaemic Encephalopathy

Term neonates diagnosed with Hypoxic Ischaemic Encephalopathy (HIE) and receiving therapeutic hypothermia.

Acute pulmonary hypertension

Term neonates diagnosed with Acute Pulmonary Hypertension of the Newborn (aPHN), excluding those with CDH.

Bronchopulmonary Dysplasia

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.

Healthy preterms

(\<36 weeks' gestation) admitted to the NICU and transitional care. Stratified into extreme preterm, moderately preterm and late preterm.

Healthy term controls

(\>36 weeks' gestation) who are well and on postnatal wards.

Eligibility Criteria

• Age: 0 Minutes - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead

Study Sites (1)

Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth; Hypoxia-Ischemia, Brain; Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

Asad Abbas Dr Asad Abbas, MD MBBS FRCPCH

CONTACT

+441214721377; asad.abbas1@nhs.net

Andrew Pearce Dr Andrew Pearce, MBBS MRCPCH

CONTACT

andrewjames.pearce@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The study protocol will be published as part of registration on clinicaltrials.gov. The anonymised participant-level dataset, statistical code, and Final Study Report may be made available through institutional repositories or by request, subject to ethical approvals, consent, and data protection safeguards. These materials will be shared no later than 12 months after final study reporting or publication. Access will require appropriate agreements and will follow national guidance on open data sharing.
• Access Criteria: De-identified individual participant data (IPD) from this study will be available upon reasonable request to the Chief Investigator, subject to approval of a study proposal and any necessary data-sharing agreements.

Locations

GB (1)