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

Birmingham Women's NHS Foundation Trust

Status: Not yet enrolling

Conditions: Premature Baby; Pulmonary Hypertension of Newborn; Chronic Lung DIsease; Hypoxic Ischaemic Encephalopathy (HIE); Congenital Diaphragmatic Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT07364682

25/BW/OGN/NO/984

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: Under 8 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

190 participants in 6 patient groups

Congenital Diaphragmatic Hernia

Description:

Term neonates diagnosed with Congenital Diaphragmatic Hernia (CDH)

Hypoxic Ischaemic Encephalopathy

Description:

Term neonates diagnosed with Hypoxic Ischaemic Encephalopathy (HIE) and receiving therapeutic hypothermia.

Acute pulmonary hypertension

Description:

Term neonates diagnosed with Acute Pulmonary Hypertension of the Newborn (aPHN), excluding those with CDH.

Bronchopulmonary Dysplasia

Description:

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

Description:

(\<36 weeks' gestation) admitted to the NICU and transitional care. Stratified into extreme preterm, moderately preterm and late preterm.

Healthy term controls

Description:

(\>36 weeks' gestation) who are well and on postnatal wards.