Myocardial Deformation Before and After Birth

March 2, 2023 updated by: Gottfried Greve, Haukeland University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Before, during and after birth major changes take place in the cardiovascular system. The last weeks prior to birth there is an oxidative stress and after birth, there is normally a large step up in blood oxygen tension when the lungs take over oxidation of the blood. Simultaneously there are changes in the vascular resistance in both the pulmonary- and systemic part of the circulation and ductus venous, the arterial duct, and foramen ovale close. Combined these will significantly alter the physical conditions under which the myocardium is supposed to work.

This project will have five arms, all based on measurements of myocardial function and coronary perfusion by speckle tracking echocardiography (STE) in the last trimester of the pregnancy and in newborns with different gestational age and in sick newborns where myocardial function is affected by medical treatment or is an important part of the clinical situation.

  1. Obtaining normal values for strain during the last trimester of the pregnancy and the first days after birth in child born to term.

    Hypothesis: After birth, there will be higher STE values in the left ventricle than before birth. This will increase further the first days post-partum in parallel with an altered hemodynamic situation and oxygen demand of the infant. The STE changes will take place at the same time, as there is an increased Doppler velocity in the aorta, the pulmonary artery and the coronary arteries

    Mothers (N= 150) will be recruited when they are coming to a routine fetal ultrasound scan. It will be made an echo-examination once per week from week 37 until birth. After birth the degree of placental transfusion (late cord clamping or not) will be noticed. Ventricular size, Doppler velocities in the ascending aorta and pulmonary artery, STE and coronary flow during the first three days of life and one year of age will be assessed

  2. Evaluate the effect of maternal obesity on cardiac function in newborns up to one year of age.

    Hypothesis: Maternal sever obesity will result in reduced cardiac function in their neonates. However, cardiac function will normalize within the first year of life. A reduction in afterload will reduce strain measured by STE and coronary.

    Mothers (N=75) with sever obesity will be recruited from the outpatient clinic for obese women. First day after birth, the newborn will have a comprehensive echocardiographic examination within the first few hours, then the two following days, at the day equivalent to gestational age 42+0 weeks and finally at 1 year of age. Cardiac morphology, ventricular sizes and Doppler velocities in the ascending aorta and pulmonary artery as well as a strain measured by STE for both ventricles will be assessed. Fetal malformations or diseases will result in exclusion from the study.

  3. Measuring deformation when preload is increased by intravenous fluid treatment and blood transfusion Hypothesis: Increased preload in the form of saline infusion or blood transfusion will result in a temporary increase of STE and coronary blood flow.

    Newborns (N=25 blood transfusion and 25 NaCl-infusion) who need infusion of sodium chloride (NaCl 9mg) / ml or transfusion of packed red blood cellssuspended in 100 mL of saline- adenine-glucose-mannitol (SAGMAN) will be recruited. To obtain rehydration or optimization of intravascular volume it is common to provide NaCl 9 mg/ml, 10-20 ml/kg in 10-120 minutes. Blood transfusion is used in severe anemia and hemolytic diseases. The regular blood transfusion dose is SAGMAN packed red blood cells10-15ml/ kg body weight over 2-3 hours. Children requiring exchange transfusion, with heart failure or congenital heart defects will be excluded.

  4. Measuring deformation when afterload and heart rate are increased during infusion of catecholamines.

    Hypothesis: Dopamine, epinephrine and/ or nor-epinephrine will increase heart rate and blood pressure and due to this increase the strain measured by STE, coronary blood flow, and Doppler velocity in the aorta pulmonary artery.

    Newborns (N=25) who need dopamine (2.5 to 15 ug/kg /min iv.) and or epinephrine / nor-epinephrine to maintain an adequate blood pressure will be recruited. Only children where an echo-exam before starting treatment is possible will be recruited. If the treatment does not achieve a rise in the blood pressure above the 2.5 percentile for gestational age, the baby will be excluded.

  5. Measuring deformation when afterload (volume) is reduced following pharmacological closure of a patent ductus arteriosus.

Hypothesis: A reduction in afterload will reduce strain measured by STE and coronary.

Patients (N=25) with a suspected patent ductus arteriosus (PDA) are always referred to echocardiography before starting treatment with Indomethacin and after the treatment has stopped. Present clinical procedures for closure of the ductus will be followed, . Time of echocardiography will be standardized to just before and at least 12 hours after the last dose of Ibuprofen has been provided (t½ ≈ 2.5-11 hrs.).

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5020
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Either recruited during pregnancies or as newborns

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fetuses of normal weight women
Fetuses of normal pregnancies of normal weight mothers are included from gestational week 37
Fetuses of severely obese women
Fetuses of normal pregnancies of severly obese mothers are included from gestational week 37
New-borns in need of blood transfusion
Neonates mainly receive blood due to blood loss, often because of repeated blood sampling
Drug: Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine
Treatment/ intervention given according to standard protocols at the Neonatal Intensive Care Unit
Other Names:
  • Volume treatment
  • Blood pressure elevation
New-borns in need for closure of the arterial duct
Neonates mainly receive medication (Ibuprofen) because of symptoms like apnea, due to their patent arterial duct.
Drug: Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine
Treatment/ intervention given according to standard protocols at the Neonatal Intensive Care Unit
Other Names:
  • Volume treatment
  • Blood pressure elevation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in myocardial function
Time Frame: Maximum 1 year and 5 weeks
Per cent change in longitudinal global strain
Maximum 1 year and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2017

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Eventually strain data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Newborn Morbidity

Clinical Trials on Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe