Umbilical Cord Milking in Non-Vigorous Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Umbilical Cord Milking in Non-Vigorous Infants

Conditions
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Birth Asphyxia

Intervention / Treatment
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* Procedure: Umbilical Cord Milking
* Procedure: Early Cord Clamping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cluster Randomized Crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umbilical Cord Milking<br>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<br>* 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.<br>|
| Active Comparator: Early Cord Clamping<br>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<br>* The umbilical cord is clamped within 30 seconds of delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental Transfusion | Estimated by single hemoglobin measurement | 12-48 hours of life | 
| Therapeutic Hypothermia (Cooling) | Cooling to 33.5 degrees C for 72 hours within the first 6 hours of life | 72 hours of life | 
| Use of volume expander | Treated with blood products or normal saline bolus to support blood pressure | Through hospital stay, up to 120 days | 
| Hyperbilirubinemia | Total bilirubin per Bhutani nomogram | First week of life | 
| Death | Death prior to discharge | From birth to date of death or discharge, whichever occurs first, assessed up to 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation