Umbilical Cord Milking in Non-Vigorous Infants (MINVI)

Sharp HealthCare

Status: Completed

Conditions: Birth Asphyxia

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03631940

MINVI

5R01HD096023-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,730 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,730 participants in 2 patient groups

Umbilical Cord Milking

Experimental 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 ECC 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 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.

Treatment:

Procedure: Early Cord Clamping