Effects of Milking the Umbilical Cord on Systemic Blood Flow

Not Applicable

Completed

• Conditions: Abnormal Vascular Flow
• Interventions: Procedure: Immediate Cord Clamping; Procedure: Umbilical Cord Milking

• Registration Number: NCT01434732
• Lead Sponsor: Sharp HealthCare

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Cord Clamping	Immediate Cord Clamping	Umbilical cord is clamped soon after birth without any milking of the cord.
Umbilical Cord Milking	Umbilical Cord Milking	Umbilical Cord Milking involved milking the umbilical cord at birth.

Primary Outcome Measures

Name	Time	Method
Superior Vena Cava Flow	6 hours	Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours.

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental Outcomes	between 18 and 36 months of life	Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have improved neurodevelopmental outcomes. Neurodevelopmental follow-up data including cognitive, language, motor, social-emotional, and adaptive behavior composite scores from the Bayley Scales of Infant and Toddler Development (BSID-III) will be recorded when available. The presence of cerebral palsy, hearing and visual impairment will also be recorded when available.
number of blood transfusions	36 weeks corrected gestational age	Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have fewer blood transfusions at 36 weeks corrected gestational age.
Blood Pressure	30 hours of life	Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 30 hours of life.
Superior Vena Cava Flow	30 hours of life	Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 30 hours.

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States