Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 11:52 AM
Study NCT ID:
NCT01434732
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2011-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Milking the Umbilical Cord on Systemic Blood Flow
Sponsor:
Sharp HealthCare
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: