Chronic Lung DIsease, Congenital Diaphragmatic Hernia, Hypoxic Ischaemic Encephalopathy (HIE), Premature Baby, Pulmonary Hypertension of Newborn
Conditions
Keywords
Speckle Tracking Echocardiography, STE, Functional echocardiography, Neonatal Performed Echocardiography
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. 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.
Interventions
None listed
Sponsors
Birmingham Women's NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements | By September 2027 | The investigators will use intra-class correlation coefficients (ICC), Bland-Altman limits of agreement, and coefficient of variation (CV) for key STE parameters. |
| To compare STE-derived parameters with conventional echocardiographic measures of cardiac function. | By September 2027 | 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). |
| To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate | By September 2027 | 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. |
Countries
United Kingdom
Contacts
CONTACTAsad Abbas Dr Asad Abbas, MD MBBS FRCPCH
CONTACTAndrew Pearce Dr Andrew Pearce, MBBS MRCPCH
Outcome results
None listed