Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial

Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.

Study Overview

• Status: Terminated
• Conditions: Prematurity
• Intervention / Treatment: Procedure: Immediate cord clamping; Procedure: Milking group

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Preterm neonates delivered between 24 0/7 and 32 6/7
• Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
• Written parental consent

Exclusion Criteria:

• Multiple gestation pregnancies (twins or higher order multiples)
• Rh or other antibody sensitization
• Hydrops fetalis
• Known major congenital abnormality
• Suspected abruptio placentae

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate umbilical cord clamping; The umbilical cord will be clamped immediately after delivery.	Procedure: Immediate cord clamping; The umbilical cord will be clamped and cut immediately after delivery of the neonate.
Experimental: Cord milking group; The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.	Procedure: Milking group; The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin during NICU course	within 24 hours of birth and through NICU stay

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	6 months
1-min Apgar	at 1 minute of life
5 min Apgar	at 5 minutes of life
Blood Sugar upon admission to NICU	within 1 hour of birth
Temperature on admission to NICU	within 1 hour of birth
Cord blood pH	within 1 hour of birth
Blood pressure upon admission to NICU	within 1 hour of birth
Number of volume challenges in first 24 hours of life	at 24 hours of birth
Days requiring ventilation	2 months
Neonatal death	6 months
Intraventricular hemorrhage	6 months
Number and volume of blood transfusions	10 units
duration of phototherapy	1 month
Maximum serum bilirubin	1 month

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Jessica Bienstock, MD MPH, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: prematurity; neonate; umbilical cord; cord milking
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NA_00046760