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

NCT03798093 | Completed Results DMC

• 1 other identifier: MINVI Echo Study
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Asphyxia

Keywords

Umbilical Cord Milking; Immediate Cord Clamping; Resuscitation

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Output

  Left ventricular output measurements taken by cardiac ultrasound.

  12 ± 6 hours of life

Secondary Outcomes (4)

• Neonatal Right Ventricular Output

  12 ± 6 hours of life

• Neonatal Superior Vena Cava Flow

  12 ± 6 hours of life

• Neonatal Peak Systolic Strain

  12 ± 6 hours of life

• Neonatal Peak Systolic Velocity

  12 ± 6 hours of life

Other Outcomes (3)

• Tricuspid Annular Plane Systolic Excursion Measurement in Neonate

  12 ± 6 hours of life

• Number of Neonates With a Patent Ductus Arteriosus

  12 ± 6 hours of life

• Neonatal Direction of Ductal Shunt

  12 ± 6 hours of life

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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.

Procedure: Umbilical Cord Milking

Early Cord Clamping

ACTIVE COMPARATOR

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.

Procedure: Early Cord Clamping

Interventions

Umbilical Cord Milking PROCEDURE

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.

Umbilical Cord Milking

Early Cord Clamping PROCEDURE

The umbilical cord is clamped within 60 seconds of delivery.

Early Cord Clamping

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Non-vigorous newborns born between 35-42 weeks gestation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharp HealthCare: lead
• Sharp Mary Birch Hospital for Women & Newborns: collaborator

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (1)

• Katheria A, Mercer J, Poeltler D, Morales A, Torres N, Lakshminrusimha S, Singh Y. Hemodynamic Changes with Umbilical Cord Milking in Nonvigorous Newborns: A Randomized Cluster Cross-over Trial. J Pediatr. 2023 Jun;257:113383. doi: 10.1016/j.jpeds.2023.03.001. Epub 2023 Mar 11.

  PMID: 36914049 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Anup Katheria
• Organization: Sharp Healthcare

Anup.Katheria@sharp.com

8589394170

Study Officials

• Anup Katheria, MD

  Sharp Mary Birch Hospital for Women & Newborns

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cardiac research sonographers that obtained study measurements were blinded to the study intervention
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neonatal Research Institute

Model Details: Cluster Randomized Crossover

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: January 7, 2019
• Primary Completion: June 1, 2021
• Study Completion: November 4, 2022
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)