MINVI Echocardiography Sub-Study
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 1/19/2019 |
Start Date: | January 7, 2019 |
End Date: | June 2021 |
Contact: | Anup Katheria, MD |
Email: | anup.katheria@sharp.com |
Phone: | 858-939-4170 |
Echocardiography Substrudy of the Umbilical Cord Milking in Non Vigorous Infants Trial
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing
data collection. As part of the data collection, an optional echocardiogram will be performed
if the parent consents.
data collection. As part of the data collection, an optional echocardiogram will be performed
if the parent consents.
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing
data collection. As part of the data collection, an optional echocardiogram will be performed
if the parent consents. The consent will have a check box to indicate if they consent to the
additional test.
Echocardiographic measurements will be performed on all infants at 12 hours +/-3 hours of age
by our research sonographers who are blinded to infant randomization. Measurements will be
taken according to a standard operating procedure to assess systemic blood flow, by superior
vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular
output (LVO) (ml/kg/min), measures of left and right venitricular tissue Doppler and strain
imaging. These measurements will be performed off line at a later time. Data will be entered
into REDCap.
If any structural abnormalities are found, the attending pediatrician will be notified of the
abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic
purposes. Any additional studies including an official complete echocardiogram and or
cardiology consultation will be left to the discretion of the attending pediatrician, as
he/she deems necessary
data collection. As part of the data collection, an optional echocardiogram will be performed
if the parent consents. The consent will have a check box to indicate if they consent to the
additional test.
Echocardiographic measurements will be performed on all infants at 12 hours +/-3 hours of age
by our research sonographers who are blinded to infant randomization. Measurements will be
taken according to a standard operating procedure to assess systemic blood flow, by superior
vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular
output (LVO) (ml/kg/min), measures of left and right venitricular tissue Doppler and strain
imaging. These measurements will be performed off line at a later time. Data will be entered
into REDCap.
If any structural abnormalities are found, the attending pediatrician will be notified of the
abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic
purposes. Any additional studies including an official complete echocardiogram and or
cardiology consultation will be left to the discretion of the attending pediatrician, as
he/she deems necessary
Inclusion Criteria:
Non-vigorous newborns born between 35-42 weeks gestation
Exclusion Criteria:
Known major congenital or chromosomal anomalies of newborn Known cardiac defects other than
small ASD, VSD and PDA Complete placental abruption/cutting through the placenta at time of
delivery Monochorionic multiples Cord Avulsion Presence of non-reducible nuchal cord
Perinatal providers unaware of the protocol
We found this trial at
1
site
San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4198
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