Premature BabyNCT07364682
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
An observational study of Premature Baby and Pulmonary Hypertension of Newborn, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 minutes to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE)
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrew Pearce Dr Andrew Pearce, MBBS MRCPCH contact
United Kingdom1 site
Birmingham Women's Hospital
Birmingham, B15 2TG
Asad Abbas Dr Asad Abbas, MD MBBS MRCPCH, +441214721377, asad.abbas1@nhs.net
Andrew Pearce Dr Andrew Pearce, MBBS MRCPCH, andrewjames.pearce@nhs.net
About this study
Official title: Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.
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:
Read more
- Healthy term and premature babies, to establish a "normal" range of heart function.
- 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.
- Conditions
- Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia, Chronic Lung DIsease
- Keywords
- Speckle Tracking Echocardiography, STE, Functional echocardiography, Neonatal Performed Echocardiography
- Medical subject headings
- Premature Birth, Hypoxia-Ischemia, Brain, Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: By September 2027
Secondary outcomes (3)
To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements
The investigators will use intra-class correlation coefficients (ICC), Bland-Altman limits of agreement, and coefficient of variation (CV) for key STE parameters.
Measured: By September 2027
To compare STE-derived parameters with conventional echocardiographic measures of cardiac function.
Correlation and agreement between speckle tracking echocardiography (STE)-derived parameters (STE derived EF, STE derived TAPSE) and conventional echocardiographic measures of cardiac function (EF by Simpson Biplane technique, M-mode TAPSE).
Measured: By September 2027
To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate
Comparison of right ventricular (RV), left ventricular (LV), and left atrial (LA) strain and strain rate parameters derived from speckle tracking echocardiography (STE) between neonates in different disease cohorts and a healthy control group.
Measured: By September 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BabyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asad Abbas, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364682
- Sponsor's protocol ID
- 25/BW/OGN/NO/984
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The REC required removal of the proposed wording allowing anonymised participant data to be shared with external researchers on request. As participants are not being consented for future research data sharing, the study has no plan to share IPD, and the ClinicalTrials.gov IPD field is therefore recorded as "No". This is an observational trial with no intervention and not a clinical trial of a device or drug.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.
- ClinicalTrials.gov ID
- NCT07364682
- Acronym / sponsor ID
- 25/BW/OGN/NO/984
- Conditions
- Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia, Chronic Lung DIsease
- Keywords
- Speckle Tracking Echocardiography, STE, Functional echocardiography, Neonatal Performed Echocardiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Healthy term and premature babies, to establish a "normal" range of heart function.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 minutes to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: By completion of data collection (September 2027)
Feasibility rate of RV, LV, and LA STE.
To describe the longitudinal changes in RV, LV, and LA STE parameters from acute illness through recovery/discharge in each disease cohort.
Time frame: By September 2027
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).
To establish normative values of simultaneously performed RV, LV and LA strain in well term and preterm neonates
Time frame: By September 2027
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.
3 secondary outcomes
To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements
Time frame: By September 2027
To compare STE-derived parameters with conventional echocardiographic measures of cardiac function.
Time frame: By September 2027
To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate
Time frame: By September 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. The REC required removal of the proposed wording allowing anonymised participant data to be shared with external researchers on request. As participants are not being consented for future research data sharing, the study has no plan to share IPD, and the ClinicalTrials.gov IPD field is therefore recorded as "No". This is an observational trial with no intervention and not a clinical trial of a device or drug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Pearce Dr Andrew Pearce, MBBS MRCPCH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Baby and Pulmonary Hypertension of Newborn, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asad Abbas Dr Asad Abbas, MD MBBS FRCPCH (+441214721377, asad.abbas1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: By completion of data collection (September 2027)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.