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.
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 +/- 6 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 ventricular tissue Doppler and strain imaging. These measurements will be performed offline 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
227
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
The umbilical cord is clamped within 60 seconds of delivery.
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Left Ventricular Output
Left ventricular output measurements taken by cardiac ultrasound.
Time frame: 12 ± 6 hours of life
Neonatal Right Ventricular Output
Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
Neonatal Superior Vena Cava Flow
superior vena cava (SVC) flow (Diameter obtained from the infraclavicular view (hybrid view) and doppler assessment from the subcostal view of the neonatal echocardiogram exam performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
Neonatal Peak Systolic Strain
This measurement reflects the deformation (strain) of the heart muscle during systole (the phase of the heartbeat when the heart contracts) relative to its original length. More negative values indicate better myocardial function while values closer to 0 suggest impaired myocardial function.
Time frame: 12 ± 6 hours of life
Neonatal Peak Systolic Velocity
Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
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