Меню
Набор скоро начнётся NCT07364682

Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography

— Наблюдательное Premature Baby Pulmonary Hypertension of Newborn Hypoxic Ischaemic Encephalopathy (HIE) Congenital Diaphragmatic Hernia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia. Базовые параметры: 0 Minutes — 8 Weeks · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.

Обзор

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.

Первичные конечные точки

  • 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. [Срок оценки: 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. [Срок оценки: By September 2027]
  • To establish normative values of simultaneously performed RV, LV and LA strain in well term and preterm neonates [Срок оценки: By September 2027]
Вторичные конечные точки (3)
  • To evaluate the intra-observer and inter-observer reproducibility of RV, LV, and LA STE measurements [Срок оценки: By September 2027]
  • To compare STE-derived parameters with conventional echocardiographic measures of cardiac function. [Срок оценки: By September 2027]
  • To compare RV, LV, and LA STE parameters between the different disease cohorts and a cohort of healthy control neonate [Срок оценки: By September 2027]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Birmingham Women's Hospital — Birmingham

Идентификаторы

NCT: NCT07364682 · 25/BW/OGN/NO/984

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗