Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Minutes 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •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)
排除标准
- •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.
研究组 & 干预措施
Healthy term controls
(>36 weeks' gestation) who are well and on postnatal wards.
Congenital Diaphragmatic Hernia
Term neonates diagnosed with Congenital Diaphragmatic Hernia (CDH)
Healthy preterms
(<36 weeks' gestation) admitted to the NICU and transitional care. Stratified into extreme preterm, moderately preterm and late preterm.
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.
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.
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
- To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements(By September 2027)
- To compare STE-derived parameters with conventional echocardiographic measures of cardiac function.(By September 2027)
- To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate(By September 2027)
研究者
Asad Abbas
Consultant Neonatologist
Birmingham Women's NHS Foundation Trust