Clinical trial

Myocardial Deformation Before and After Birth, and Under Altered Preload, Afterload and Heart Rate in New-borns

Name
2015/1918
Description
Knowledge on the changes in myocardial function in the last weeks before birth and during the first year of life is limited. Through fetal and post-natal echocardiography we intend to describe these changes using myocardial tissue recognition techniques (Speckle tracking echocardiography and Tissue Doppler echocardiography) in healthy neonates, born to term of healthy women after uncomplicated pregnancies. We will compare the findings in this cohort to a cohort of neonates born to term of women with severe pre-pregnancy obesity. Sick neonates in intensive care units with various cardiac and non-cardiac conditions are often exposed to treatment that may affect both their cardiac function and important echo-variables per se. Using echocardiography, we will examine these changes in neonates treated with blood transfusion, catecholamines and in those treated with Ibuprofen due to a haemodynamic significant arterial duct.
Trial arms
Trial start
2017-04-04
Estimated PCD
2023-12-01
Trial end
2025-12-01
Status
Active (not recruiting)
Treatment
Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine
Treatment/ intervention given according to standard protocols at the Neonatal Intensive Care Unit
Arms:
New-borns in need for closure of the arterial duct, New-borns in need of blood transfusion
Other names:
Volume treatment, Blood pressure elevation
Size
300
Primary endpoint
Changes in myocardial function
Maximum 1 year and 5 weeks
Eligibility criteria
Inclusion Criteria: * Normal pregnancies * Newborns in need of blood transfusion * Newborns in need of medical closure of the arterial duct * Maternal obesity Exclusion Criteria: * Abnormal pregnancies except maternal obesity * Congenital heart defects * Other malformation syndromes
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-03-06

1 organization

1 product

3 indications

Indication
Obesity