MINVI Echocardiography Sub-Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Echocardiography Substudy of the Umbilical Cord Milking in Non Vigorous Infants Trial

Conditions
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Birth Asphyxia

Intervention / Treatment
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* Procedure: Umbilical Cord Milking
* Procedure: Early Cord Clamping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cluster Randomized Crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umbilical Cord Milking<br>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. | Procedure: Umbilical Cord Milking<br>* 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.<br>|
| Active Comparator: Early Cord Clamping<br>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. | Procedure: Early Cord Clamping<br>* The umbilical cord is clamped within 30 seconds of delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output | Cardiac Output measured by Left Ventricular Output | 12 +/- 6 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Ventricular Output | Obtained from the modified short axis view of Cardiac Ultrasound | 12 +/- 6 hours of life | 
| SVC Flow | SVC flow (Diameter obtained from the infaclavicular view (hybrid view), Doppler from the subcostal view) | 12 +/- 6 hours of life | 
| Peak Systolic Strain and Strain rate | Measures of Left and Right Ventricular Strain and Strain rate | 12 +/- 6 hours of life | 
| Peak Systolic Tissue Doppler | Measure of left and right ventricular peak systolic Tissue Doppler velocity | 12 +/- 6 hours of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation