Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)

Not Applicable

Completed

Interventions: Procedure: Umbilical Cord Milking
Procedure: Early Cord Clamping

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

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 atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA).
Complete placental abruption/cutting through the placenta at time of delivery.
Monochorionic multiples
Cord anomaly (i.e. cord avulsion or true knot)
Presence of non-reducible nuchal cord
Perinatal providers unaware of the protocol
Incomplete delivery data
Infants born in extremis, for whom additional treatment will not be offered.

Arm && Interventions

Group	Intervention	Description
Umbilical Cord Milking	Umbilical Cord Milking	The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials.
Early Cord Clamping	Early Cord Clamping	This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.

Primary Outcome Measures

Name	Time	Method
Left Ventricular Output	12 ± 6 hours of life	Left ventricular output measurements taken by cardiac ultrasound.

Secondary Outcome Measures

Name	Time	Method
Neonatal Right Ventricular Output	12 ± 6 hours of life	Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Neonatal Superior Vena Cava Flow	12 ± 6 hours of life	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.
Neonatal Peak Systolic Strain	12 ± 6 hours of life	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.
Neonatal Peak Systolic Velocity	12 ± 6 hours of life	Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.