Umbilical Cord Milking in Non-Vigorous Infants

NCT03631940 | Completed Results DMC

• 2 other identifiers: MINVI5R01HD096023-02
• Study Type: interventional
• Target: 1,730
• Locations: 3 countries
• Sites: 10

Brief Summary

The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.

Conditions

Birth Asphyxia

Keywords

Umbilical Cord Milking; Immediate Cord Clamping; Resuscitation

Outcome Measures

Primary Outcomes (1)

• Number of Neonatal Participants Admitted to the NICU for Predefined Criteria

  Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.

  Birth to first 48 hours of life.

Secondary Outcomes (6)

• Median Neonatal Hemoglobin Between 12 to 48 Hours of Life

  12-48 hours of life

• Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")

  Birth to 78 hours of life.

• Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life

  Birth through 24 hours of life

• Median Peak Total Serum Bilirubin in Neonates

  First week of life

• Median Transcutaneous Bilirubin in Neonates

  birth to 7 days of life

Other Outcomes (4)

• Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy

  Birth to discharge, up to 120 days of life.

• Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive

  birth to discharge, up to 120 days of life.

• Median Neonatal Admission Blood Pressure

  Birth to 48 hours of life.

Study Arms (2)

Umbilical Cord Milking

EXPERIMENTAL

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

Early Cord Clamping

ACTIVE COMPARATOR

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

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 ASD, VSD and PDA
• Complete placental abruption/cutting through the placenta at time of delivery
• Monochorionic multiples
• Cord anomaly (i.e. cord avulsion, 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
• Sharp Grossmont Hospital: collaborator
• University of Utah: collaborator
• University of Alberta: collaborator
• Poznan University of Medical Sciences: collaborator
• IWK Health Centre: collaborator
• University of California, Davis: collaborator
• Loma Linda University: collaborator
• George Washington University: collaborator
• Providence Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (10)

University of California, Davis

Davis, California, 95616, United States

Location

Loma Linda Medical Center

Loma Linda, California, 92350, United States

Location

Sharp Grossmont Hospital

San Diego, California, 91942, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225-6603, United States

Location

University of Utah/IMH

Salt Lake City, Utah, 84113, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Dalhousie University

Dalhousie, New Brunswick, E8C 2R6, Canada

Location

Poznan University of Medical Science

Poznan, Poland

Location

Related Publications (1)

• Katheria AC, El Ghormli L, Clark E, Yoder B, Schmolzer GM, Law BHY, El-Naggar W, Rittenberg D, Sheth S, Martin C, Vora F, Lakshminrusimha S, Underwood M, Mazela J, Kaempf J, Tomlinson M, Gollin Y, Rich W, Morales A, Varner M, Poeltler D, Vaucher Y, Mercer J, Finer N, Rice MM. Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants: A Secondary Analysis of the MINVI Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2416870. doi: 10.1001/jamanetworkopen.2024.16870.

  PMID: 38949814 DERIVED

Related Links

• MINVI NIRS Substudy
• MINVI Follow-up study
• MINVI Echocardiogram Substudy

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 HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• 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: August 6, 2018
• First Posted: August 15, 2018
• Study Start: January 5, 2019
• Primary Completion: June 1, 2021
• Study Completion: September 26, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (7); CA (2); PL (1)