Milking the Umbilical Cord for Extreme Preterm Infants
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/19/2018 |
| Start Date: | October 2012 |
| End Date: | July 2019 |
Milking the umbilical cord from the placental end toward the infant has been shown to benefit
preterm infants when compared to either clamping the umbilical cord immediately or waiting
delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown
to improve heart and lung function, reduces the need for blood transfusion, and reduces the
risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical
cord, however in extremely premature infants is not considered safe, since it also delays the
resuscitation that these infants need immediately after birth. Milking the umbilical cord is
believed have similar benefits to delaying the clamping of the cord, but can be done much
faster (seconds rather than minutes). In this study, the cord will milked three times over
about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for
routine care. Participants of this study will be randomly assigned to one of two study
groups: the first group will have the cord milking intervention and the second group will not
have any intervention other than routine, immediate cord clamping with routine care of mother
and infant. Data will be collected about the mother prior to delivery and data will also be
collected about the baby using computerized health records. The data will look at short term
changes in red blood cell volumes, the need for blood transfusions, and rates of known
complications of prematurity, including longer term developmental complications at 18-24
months.
The hypothesis is that milking the umbilical cord before cutting the cord will lead to a
higher hemoglobin concentration and decrease the need for blood transfusions in extremely
preterm neonates compared to the current standard of immediately clamping the umbilical cord.
preterm infants when compared to either clamping the umbilical cord immediately or waiting
delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown
to improve heart and lung function, reduces the need for blood transfusion, and reduces the
risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical
cord, however in extremely premature infants is not considered safe, since it also delays the
resuscitation that these infants need immediately after birth. Milking the umbilical cord is
believed have similar benefits to delaying the clamping of the cord, but can be done much
faster (seconds rather than minutes). In this study, the cord will milked three times over
about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for
routine care. Participants of this study will be randomly assigned to one of two study
groups: the first group will have the cord milking intervention and the second group will not
have any intervention other than routine, immediate cord clamping with routine care of mother
and infant. Data will be collected about the mother prior to delivery and data will also be
collected about the baby using computerized health records. The data will look at short term
changes in red blood cell volumes, the need for blood transfusions, and rates of known
complications of prematurity, including longer term developmental complications at 18-24
months.
The hypothesis is that milking the umbilical cord before cutting the cord will lead to a
higher hemoglobin concentration and decrease the need for blood transfusions in extremely
preterm neonates compared to the current standard of immediately clamping the umbilical cord.
Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do
not have congenital anomalies.
not have congenital anomalies.
Inclusion Criteria:
- pregnant women/child pairs with infants born at an estimated gestation age between 24
0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or
ultrasound
- informed consent obtained by the pregnant women prior to delivery of the infant.
Exclusion Criteria:
- pregnancy with a multiple gestation
- infants with pre- or postnatally diagnosed major congenital anomalies or probable
chromosomal abnormalities
- infants with hydrops fetalis
We found this trial at
2
sites
Saint Louis, Missouri 63117
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Saint Louis, Missouri 63104
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