MINVI Echocardiography Sub-Study

Echocardiography Substudy 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.

Study Overview

• Status: Completed
• Conditions: Birth Asphyxia
• Intervention / Treatment: Procedure: Umbilical Cord Milking; Procedure: Early Cord Clamping

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 +/-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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Umbilical Cord Milking; 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.
Active Comparator: 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.	Procedure: Early Cord Clamping; The umbilical cord is clamped within 30 seconds of delivery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: Sharp Mary Birch Hospital for Women & Newborns
• Investigators: Principal Investigator: Anup Katheria, MD, Sharp Mary Birch Hospital for Women & Newborns

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Resuscitation; Umbilical Cord Milking; Immediate Cord Clamping
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: MINVI Echo Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No