Umbilical Cord Milking in Non-Vigorous Infants

Birth Asphyxia Clinical Trial

— MINVI  

Official title:

Umbilical Cord Milking in Non-Vigorous Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631940
• Other study ID #: MINVI
• Secondary ID: 5R01HD096023-02
• Status: Completed
• Phase: N/A
• Start date: January 5, 2019
• Est. completion date: September 26, 2023

Study information

• Verified date: April 2024
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.

The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1730
• Est. completion date: September 26, 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 42 Weeks

Eligibility

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 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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia

Intervention

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.
• Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.

Locations

Country	Name	City	State
Canada	Dalhousie University	Dalhousie	New Brunswick
Canada	University of Alberta	Edmonton	Alberta
Poland	Poznan University of Medical Science	Poznan
United States	University of California, Davis	Davis	California
United States	Loma Linda Medical Center	Loma Linda	California
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	University of Utah/IMH	Salt Lake City	Utah
United States	Sharp Grossmont Hospital	San Diego	California
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	George Washington University	Washington	District of Columbia

Sponsors (12)

Lead Sponsor	Collaborator
Sharp HealthCare	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), George Washington University, IWK Health Centre, Loma Linda University, Poznan University of Medical Sciences, Providence Hospital, Sharp Grossmont Hospital, Sharp Mary Birch Hospital for Women & Newborns, University of Alberta, University of California, Davis, University of Utah

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory-Level of Hypoxic Ischemic Encephalopathy	Mild, moderate or severe	Through hospital stay, up to 120 days
Other	Exploratory-Length of Stay	Number of days from birth to discharge home	Through hospital stay, up to 120 days
Other	Exploratory-Blood Pressure	Blood Pressure on Admission to NICU	First 48 hours of life
Other	Exploratory-Resuscitation interventions	Level of resuscitation interventions at delivery	First hour of life
Primary	NICU Admission	Admission to the Neonatal Intensive Care Unit for Study-specific criteria	Delivery room death or Admission to the NICU in the first 48 hours of life
Secondary	Placental Transfusion	Estimated by single hemoglobin measurement	12-48 hours of life
Secondary	Therapeutic Hypothermia ("Cooling")	Cooling to 33.5 degrees C for 72 hours within the first 6 hours of life	72 hours of life
Secondary	Use of volume expander	Treated with blood products or normal saline bolus to support blood pressure	Through hospital stay, up to 120 days
Secondary	Hyperbilirubinemia	Total bilirubin per Bhutani nomogram	First week of life
Secondary	Death	Death prior to discharge	From birth to date of death or discharge, whichever occurs first, assessed up to 180 days

External Links

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