Clinical Trials Directory

Trials / Completed

CompletedNCT01434732

Effects of Milking the Umbilical Cord on Systemic Blood Flow

A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Sharp HealthCare · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUmbilical Cord MilkingUCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times.
PROCEDUREImmediate Cord ClampingThe umbilical cord will be clamped soon after birth without any milking of the umbilical cord.

Timeline

Start date
2011-04-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2011-09-15
Last updated
2017-10-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01434732. Inclusion in this directory is not an endorsement.