Premature babies are at risk for bleeding in their brain, which often results in developmental delays or other neurological problems such as cerebral palsy. There is a link between low blood flow to the brain and the development of intraventricular hemorrhage (IVH) and neurological injury. This could be due to the lack of oxygen delivered to the brain. Unfortunately, no therapy has been shown to be effective in preventing low blood flow to the brain in premature babies. One possible way of improving blood flow is to allow premature infants to passively receive more blood from the umbilical cord and placenta by delaying the clamping of the umbilical cord after the infant is born. However, a delayed clamping of the umbilical cord is not usually done in extremely premature or sick babies, because it postpones their initial stabilization and contributes to neonatal hypothermia. Milking, or stripping, the umbilical cord is another way to actively give premature babies more blood while minimizing delays in treatment. Umbilical cord milking in preterm infants has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life. Whether umbilical cord milking enhances blood flow to the brain is not yet known.
Specific Aims : There are two aims of this study: 1) To evaluate the hemodynamic effects of umbilical cord milking (UCM) compared to immediate cord clamping (ICC) in premature (<32 weeks gestation) infants 2) To assess and compare the clinical outcomes of infants receiving UCM and ICC during their hospitalization. Design: This study is a randomized partially blinded controlled clinical trial to evaluate systemic blood flow i premature infants receiving UCM or ICC. UCM will be performed by grasping the umbilical cord and milking about 20 cm of cord towards the baby three times in succession, as described previously. Serial heart ultrasounds will be performed at 6, 18 and 30 hours of life. The primary outcome measure will be superior vena cava (SVC) flow, an index of systemic blood flow. Clinical outcomes will include resuscitation interventions, cerebral tissue saturations (StO2), fractional oxygen extraction (FOE), blood pressure, and urine output during the first 2 days of life, incidence of IVH, and number of blood transfusions received. Laboratory studies will include hemoglobin levels at birth, 12 hours and 1 month of life. This will be the first randomized study to look at the effect of UCM on important measures of blood flow in very preterm infants. Increased blood flow may reduce the incidence of brain bleeding and subsequent developmental problems in very premature babies.

Public Health Relevance

Despite improved neonatal intensive care, 1 out of every 4 extremely premature infant has bleeding in their brain. Bleeding in the brain has been linked with low blood flow in the heart. This will be the first study to evaluate milking the umbilical cord before cutting it, a method used to transfuse placental blood from the umbilical cord into the baby, to determine if this approach will enhance blood flow after birth and improve outcomes such as reducing the incidence of brain bleeds.

Agency
National Institute of Health (NIH)
Type
Small Research Grants (R03)
Project #
5R03HD072934-02
Application #
8706195
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Raju, Tonse N
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Sharp Memorial Hospital
Department
Type
DUNS #
City
San Diego
State
CA
Country
United States
Zip Code
92123