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

Sharp HealthCare

Status: Completed

Conditions: Birth Asphyxia

Treatments: Procedure: Umbilical Cord Milking; Procedure: Early Cord Clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT03798093

MINVI Echo Study

Details and patient eligibility

About

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.

Full 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

Enrollment: 227 patients

Sex: All

Ages: 35 to 42 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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227 participants in 2 patient groups

Umbilical Cord Milking

Active Comparator group

Description:

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 Early Cord Clamping as we have demonstrated in our previous trials.

Treatment:

Procedure: Umbilical Cord Milking

Early Cord Clamping

Active Comparator group

Description:

This will occur by clamping the umbilical cord as soon as possible. Since both Early Cord Clamping and Umbilical Cord Milking 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.

Treatment:

Procedure: Early Cord Clamping