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Effects of Milking the Umbilical Cord on Systemic Blood Flow

NCT ID: NCT01434732

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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

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Abnormal Vascular Flow

Keywords

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Superior vena cava flow umbilical cord milking hemodynamics systemic blood flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Umbilical Cord Milking

Umbilical Cord Milking involved milking the umbilical cord at birth.

Group Type EXPERIMENTAL

Umbilical Cord Milking

Intervention Type PROCEDURE

UCM 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.

Immediate Cord Clamping

Umbilical cord is clamped soon after birth without any milking of the cord.

Group Type ACTIVE_COMPARATOR

Immediate Cord Clamping

Intervention Type PROCEDURE

The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.

Interventions

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Umbilical Cord Milking

UCM 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.

Intervention Type PROCEDURE

Immediate Cord Clamping

The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.

Intervention Type PROCEDURE

Other Intervention Names

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stripping the umbilical cord routine clamping of the umbilical cord

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sharp HealthCare

OTHER

Sponsor Role lead

Responsible Party

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Anup Katheria, M.D.

Director of Neonatal Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anup C Katheria, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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UCSD Medical Center

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29246467 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24709780 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24560179 (View on PubMed)

Other Identifiers

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CORDMILK

Identifier Type: -

Identifier Source: org_study_id