Clinical trial NCT01434732: Effects of Milking the Umbilical Cord on Systemic Blood Flow
Official title: A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Vascular Flow
Keywords: Superior vena cava flow
umbilical cord milking
hemodynamics
systemic blood flow
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking 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.

Detailed description: The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.

This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.

Eligibility criteria: Inclusion Criteria:

* infants \< 32 weeks gestation

Exclusion Criteria:

* obstetrician's refusal to participate
* multiple gestations (if Di-Mo placentation) surrogate delivery
* parental desire for cord blood banking
* major congenital anomalies
* severe maternal illness
* placental abruption or previa
* ruptured uterus at delivery, or hemoperitoneum

Primary outcomes:
measure: Superior Vena Cava Flow
timeFrame: 6 hours
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 hours of life
measure: Neurodevelopmental Outcomes
timeFrame: between 18 and 36 months of life
measure: number of blood transfusions
timeFrame: 36 weeks corrected gestational age
measure: Superior Vena Cava Flow
timeFrame: 18 hours of life
measure: Superior Vena Cava Flow
timeFrame: 30 hours of life
measure: Blood Pressure
timeFrame: at 18 hours of life
measure: Blood Pressure
timeFrame: 30 hours of life
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: UCSD
name: Anup C Katheria, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
citation: Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014.
citation: Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20.