NCT04060381

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

6.7 years

First QC Date

August 15, 2019

Last Update Submit

March 2, 2023

Conditions

Myocardial DysfunctionNewborn MorbidityMaternal Obesity

Keywords

Spackle tracking echocardiographyTissue dopplerNeonatesInfantsMaternal obesity

Outcome Measures

Primary Outcomes (1)

  • Changes in myocardial function

    Per cent change in longitudinal global strain

    Maximum 1 year and 5 weeks

Study Arms (4)

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

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

Interventions

Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamineDRUG

Treatment/ intervention given according to standard protocols at the Neonatal Intensive Care Unit

Also known as: Volume treatment, Blood pressure elevation
New-borns in need for closure of the arterial ductNew-borns in need of blood transfusion

Eligibility Criteria

AgeUp to 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Either recruited during pregnancies or as newborns

You may qualify if:

  • Normal pregnancies
  • Newborns in need of blood transfusion
  • Newborns in need of medical closure of the arterial duct
  • Maternal obesity

You may not qualify if:

  • Abnormal pregnancies except maternal obesity
  • Congenital heart defects
  • Other malformation syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5020, Norway

Location

MeSH Terms

Conditions

Pregnancy in Obesity

Interventions

Blood TransfusionIbuprofenEpinephrineNorepinephrineDopamine

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant/ Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 19, 2019

Study Start

April 4, 2017

Primary Completion

December 1, 2023

Study Completion

December 1, 2025

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

NO(1)