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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04060381
Other study ID # 2015/1918
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 4, 2017
Est. completion date December 2025

Study information

Verified date March 2023
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Drug:
Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine
Treatment/ intervention given according to standard protocols at the Neonatal Intensive Care Unit

Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in myocardial function Per cent change in longitudinal global strain Maximum 1 year and 5 weeks
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