Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia. Basic parameters: 0 Minutes — 8 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.
Overview
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.
Primary outcome measures
- 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)]
- 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]
- To establish normative values of simultaneously performed RV, LV and LA strain in well term and preterm neonates [Time frame: By September 2027]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Birmingham Women's Hospital — Birmingham
Identifiers
NCT: NCT07364682 · 25/BW/OGN/NO/984