An observational study in Premature Baby, Pulmonary Hypertension of Newborn and Hypoxic Ischaemic Encephalopathy (HIE), sponsored by Birmingham Women's NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 0 Minutes to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Birmingham Women's NHS Foundation Trust · Observational
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:
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.
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:
OR
Exclusion Criteria:
Term neonates diagnosed with Congenital Diaphragmatic Hernia (CDH)
Term neonates diagnosed with Hypoxic Ischaemic Encephalopathy (HIE) and receiving therapeutic hypothermia.
Term neonates diagnosed with Acute Pulmonary Hypertension of the Newborn (aPHN), excluding those with CDH.
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.
(\<36 weeks' gestation) admitted to the NICU and transitional care. Stratified into extreme preterm, moderately preterm and late preterm.
(\>36 weeks' gestation) who are well and on postnatal wards.
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.
Time frame: 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).
Time frame: 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.
Time frame: By September 2027
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.
Time frame: 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).
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
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.
Time frame: By September 2027
Plan to share: 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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Birmingham Women's NHS Foundation Trust