Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | By September 2027 |
| To compare STE-derived parameters with conventional echocardiographic measures of cardiac function. |
Not provided
Inclusion Criteria:
OR
Exclusion Criteria:
Not provided
Not provided
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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asad Abbas Dr Asad Abbas, MD MBBS FRCPCH | Contact | +441214721377 | asad.abbas1@nhs.net | |
| Andrew Pearce Dr Andrew Pearce, MBBS MRCPCH | Contact | +447709684105 | andrewjames.pearce@nhs.net |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Women's Hospital | Birmingham | B15 2TG | United Kingdom |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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). |
| 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. | By September 2027 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020925 | Hypoxia-Ischemia, Brain |
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided