Trial Outcomes & Findings for Cardiac Displacement From Third Trimester to Early Childhood (NCT NCT02583763)

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

61 participants

Primary outcome timeframe

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.

Results posted on

2025-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. Echocardiography: 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age.	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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. Echocardiography: 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age.
Overall Study STARTED	21	40
Overall Study COMPLETED	18	35
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fetuses/Children With IUGR n=18 Participants 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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. Echocardiography: 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age.	Healthy Controls n=35 Participants 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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. Echocardiography: 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age.	Total n=53 Participants Total of all reporting groups
Age, Continuous	36.4 Gestational age STANDARD_DEVIATION 3.9 • n=18 Participants	39.7 Gestational age STANDARD_DEVIATION 1.5 • n=35 Participants	36.6 Gestational age STANDARD_DEVIATION 3.0 • n=53 Participants
Sex: Female, Male Female	8 Participants n=18 Participants	17 Participants n=35 Participants	25 Participants n=53 Participants
Sex: Female, Male Male	10 Participants n=18 Participants	18 Participants n=35 Participants	28 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Fetuses/Children With Fetal Growth Restriction n=18 Participants Growth restriction was defined as a prenatal estimated weight deviation more than 22% from the normal curve at a given gestational age or growth rate deviating more than 10% compared to the previous measurement in relation to the expected weight.	Healthy Controls n=35 Participants Fetuses in a control group were randomly selected among pregnant women who came for routine ultrasound during pregnancy at gestational week 18-20 having normal fetal examination with a normal estimated birth weight.
Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm	0,095 cm/s/mm = quota Standard Deviation 0,018	0,087 cm/s/mm = quota Standard Deviation 0,016

SECONDARY outcome

Timeframe: 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.

Echocardiography images of the heart's walls are outlined and the software extracts the movement in mm in the myocardial wall from end diastole to end systole. The movement of the myocardium from end diastole to end systole at the AV valve level of the septal wall is measured in mm and expressed as a ratio compared to the ventricular length in mm at the end of diastole.

Outcome measures

Outcome measures
Measure	Fetuses/Children With Fetal Growth Restriction n=18 Participants Growth restriction was defined as a prenatal estimated weight deviation more than 22% from the normal curve at a given gestational age or growth rate deviating more than 10% compared to the previous measurement in relation to the expected weight.	Healthy Controls n=35 Participants Fetuses in a control group were randomly selected among pregnant women who came for routine ultrasound during pregnancy at gestational week 18-20 having normal fetal examination with a normal estimated birth weight.
Left Chamber Longitudinal Displacement in the Septal Wall at the AV Valve Level Corrected for Ventricular Length Expressed as a Ratio.	0,112 mm/mm = ratio Standard Deviation 0,026	0,110 mm/mm = ratio Standard Deviation 0,028

SECONDARY outcome

Timeframe: At 3 months

Population: Average longitudinal 4 segmental myocardial strain at 3 months of age

Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. A 4 chamber view of the hartt is used and calculation of 6 segments (2 basal, 2 mid and 2 apical segments) were performed three times on each image and an averaged was calculated. The 2 basal segments closeset to the AV valve and the two 2 mid segments were summed and averaged into average longitudinal 4 segmental strain. Strain in % is the averege shortening of the myocardium in systole.

Outcome measures

Outcome measures
Measure	Fetuses/Children With Fetal Growth Restriction n=18 Participants Growth restriction was defined as a prenatal estimated weight deviation more than 22% from the normal curve at a given gestational age or growth rate deviating more than 10% compared to the previous measurement in relation to the expected weight.	Healthy Controls n=35 Participants Fetuses in a control group were randomly selected among pregnant women who came for routine ultrasound during pregnancy at gestational week 18-20 having normal fetal examination with a normal estimated birth weight.
Average Longitudinal 4 Segmental Strain in the Cardiac Wall. Shortening of the Myocardium in Systole.	-17.8 percentage of myocardium shortening. Standard Deviation 3.82	-20.92 percentage of myocardium shortening. Standard Deviation 3.31

Adverse Events

Fetuses/Children With IUGR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Olov Änghagen PhD student

Region Östergötland / University of Linköping

Phone: +461047246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place