The investigators will conduct a study on non-vigorous infants at birth to determine if
umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic
encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at
birth and need immediate resuscitation.

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

Hypoxic-Ischemic Encephalopathy

Birth Asphyxia

Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by inadequate blood flow
and oxygen delivery to the neonatal brain. Almost all infants with severe HIE and 30-50%
infants with moderate HIE either die or develop significant developmental delay, cerebral
palsy or other disabilities.The incidence of HIE is 1-3 per 1,000 term births in
developed countries and 15-20 times higher in developing countries (Worldwide, 0.5 to 1
million infants develop HIE each year). Therapeutic hypothermia is the only proven
therapy for infants with HIE. Even after receiving therapeutic hypothermia, one-half of
all infants with moderate and severe HIE die or develop neurological and functional
impairment. Therapeutic hypothermia is not widely available and ineffective in developing
nations.There is an urgent need for a new therapy for neonates with HIE, which can
complement hypothermia and be readily available in developing nations. Stem cell
transplantation is a potential therapy for infants with HIE. Umbilical cord blood is a
rich source of stem cells. Umbilical cord milking (UCM) may have similar effect as
autologous umbilical cord blood cell transplantation.

Preliminary evidence suggests a placental transfusion in term infants may be a
neuroprotective mechanism that can also facilitate cardiovascular transition for neonates
depressed at birth and result in decreased mortality and improved neurodevelopmental
outcomes. Infants with HIE, due to varied complications during the birth process, have
poor perfusion due to fetal blood volume loss to the placenta. However, the most common
method of providing placental blood, delayed cord clamping (DCC) cannot be performed
since infants with HIE are non-vigorous and providers often need to perform resuscitation
immediately after birth. The World Health Organization and the American College of
Obstetrics and Gynecology (ACOG) also does not recommended DCC in neonates who are
non-vigorous (limp, pale, and not breathing) at birth and require immediate
resuscitation. Umbilical cord milking (UCM) or gently squeezing cord blood toward the
baby, is an alternative to DCC, which can achieve significant placental transfusion
without delaying resuscitation. Further, UCM can be completed as quickly as immediate
cord clamping (ICC) and UCM requires minimal training and no additional staff.

The investigators hypothesized that UCM will reduce the number of infants developing
moderate to severe HIE or death in neonates who are non-vigorous at birth compared to
early cord clamping (ECC). This will be a cluster crossover randomized controlled trial.
Each hospital will be randomly assigned to use either ECC or UCM for any infant who is
non-vigorous at birth and needing resuscitation over a period of 6 months. Then the site
will change to the other method for an additional 6 months.

Umbilical cord milking

A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth

Number of infants with moderate to severe HIE or death

Professor Of Pediatrics

Number of infants with moderate to severe HIE who have abnormal brain MRI

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 20-30 centimeters
length of the umbilical cord over two seconds, repeating three additional times as
described previously. This time is not significantly different from the time for ECC.

Umbilical cord will be clamped immediately after birth (within 60 seconds)

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

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