Cardiac Displacement From Third Trimester to Early Childhood

NCT02583763 | Active Not Recruiting Results

• 1 other identifier: 2012/257-31
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

The aim is to increase awareness of the relationship between (IUGR) and cardiac function in the foetus, the development of cardiac function over time after delivery and what significance a possible early disturbed myocardial function have for the neonate and the child during the first years of life.

Conditions

IUGR; Fetal Growth Retardation; Intrauterine Growth Restriction

Keywords

pro-brain natriuretic peptide (1-76); Insulin-Like Growth Factor Binding Proteins; Insulin-Like Growth Factor I; Echocardiography; Velocity Vector Imaging; Heart Function Tests

Outcome Measures

Primary Outcomes (1)

• Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm

  Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. At each timepoint offline calculation were performed three times on each image and an averaged was calculated. The length of the heart from the level of the AV valve to the apex in left ventricle is used as a measurement for the size of the heart. As the velocity increases when the size of the heart increases a quota is used dividing the velocity by the length of the heart to be able to compare the velocity at different timepoints whe the child is growing. Quota=Left chamber velocity at septum stated in cm/s divided by ventricular length in mm.

  After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age.

Secondary Outcomes (7)

• Left Chamber Longitudinal Displacement in the Septal Wall at the AV Valve Level Corrected for Ventricular Length Expressed as a Ratio.

  After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age.

• Average Longitudinal 4 Segmental Strain in the Cardiac Wall. Shortening of the Myocardium in Systole.

  At 3 months

• Cardiac Marker Troponin T

  At birth and at 9 years of age

• Cardiac Marker N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)

  At birth and at 9 years of age

• Insulin-like Growth Factor-1 (IGF-1)

  At birth and at 9 years of age

Study Arms (2)

Fetuses/Children with IUGR

The moving sequences of the heart movement are collected at the regular ultrasound examinations during pregnancy. Following delivery the investigators plan to examine the baby with cardiac ultrasound, echocardiography, between 12 and 72 hours after delivery and again when the child is 3-4 months old and at 9 years of age. Blood sample will be taken from the umbilical cord at birth and again at 9 years of age. The investigators will analyse the blood for growth factors and cardiac markers. An additional ethical approval was accepted 2015 for analysing epigenetic factors in the children's DNA. Due to corona pandemic the follow up was delayed from 7 to 9 years of age. Approved by the ethical committee.

Other: Echocardiography; Procedure: Blood sample

Healthy Controls

The moving sequences of the heart movement are collected at two occasions approximately 4 weeks apart. This takes place during gestational weeks 28-36. Following delivery the investigators plan to examine the baby with cardiac ultrasound, echocardiography, between 12 and 72 hours after delivery and again when the child is 3-4 months old and at 9 years of age. Blood sample will be taken from the umbilical cord at birth and again at 9 years of age. The investigators will analyze the blood for growth factors and cardiac markers. An additional ethical approval was accepted 2015 for analysing epigenetic factors in the children's DNA. Due to corona pandemic the follow up was delayed from 7 to 9 years of age. Approved by the ethical committee.

Other: Echocardiography; Procedure: Blood sample

Interventions

Echocardiography OTHER

During the ultrasound examinations standardized, moving sequences of the heart will be saved. Analyzes are performed off-line and analyzed by vector velocity imaging software.

Fetuses/Children with IUGR; Healthy Controls

Blood sample PROCEDURE

The investigators will take a blood sample from the umbilical cord at birth and again at 9 years of age.

Fetuses/Children with IUGR; Healthy Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective case-control study in which fetuses from normal pregnancies will be compared with fetuses with IUGR. Parents will be asked to participate in the study in connection with the routine ultrasound examinations at the department of obstetrics to where they have been referred because of suspected IUGR. The control group will be randomly selected among pregnant women who come for routine ultrasound during pregnancy at gestational week 18-20.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Ostergotland County Council, Sweden: collaborator
• Stiftelsen Samariten: collaborator

Study Sites (2)

Dept of Obstetrics and Gynecology

Linköping, 58185, Sweden

Location

Paediatric Department University Hospital

Linköping, 59071, Sweden

Location

Related Publications (1)

• Anghagen O, Engvall J, Gottvall T, Nelson N, Nylander E, Bang P. Developmental Differences in Left Ventricular Strain in IUGR vs. Control Children the First Three Months of Life. Pediatr Cardiol. 2022 Aug;43(6):1286-1297. doi: 10.1007/s00246-022-02850-y. Epub 2022 Mar 25.

  PMID: 35333947 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will take a blood sample from the umbilical cord at birth and again at 9 years of age. The sample will be analyzed for growth factors and cardiac markers. 2015-05-20 an additional ethical approval was accepted for analyzing epigenetic factors in the children's DNA.

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Olov Änghagen PhD student
• Organization: Region Östergötland / University of Linköping

olov.anghagen@regionostergotland.se

+461047246

Study Officials

• Olov Änghagen, PhD student

  Dept of Paediatric, Linköping

  PRINCIPAL INVESTIGATOR

• Nina Nelson, Professor

  Karolinska University Hospital, Stockholm

  STUDY CHAIR

• Peter Bang, Professor

  Dept of Paediatric, Linköping

  STUDY CHAIR

• Jan Engvall, Professor

  Dept of Clinical Physiology, Linköping

  STUDY CHAIR

• Eva Nylander, Professor

  Dept of Clinical Physiology, Linköping

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatrician, PhD student

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 22, 2015
• Study Start: January 1, 2013
• Primary Completion: June 30, 2018
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Locations

SE (2)