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

Not Applicable

Terminated

• Conditions: Prematurity
• Interventions: Procedure: Immediate cord clamping; Procedure: Milking group

• Registration Number: NCT01819532
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immediate umbilical cord clamping	Immediate cord clamping	The umbilical cord will be clamped immediately after delivery.
Cord milking group	Milking group	The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.

Primary Outcome Measures

Name	Time	Method
Hemoglobin during NICU course	within 24 hours of birth and through NICU stay

Secondary Outcome Measures

Name	Time	Method
Days requiring ventilation	2 months
Temperature on admission to NICU	within 1 hour of birth
Maximum serum bilirubin	1 month
Blood Sugar upon admission to NICU	within 1 hour of birth
1-min Apgar	at 1 minute of life
5 min Apgar	at 5 minutes of life
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
Neonatal death	6 months
Length of hospital stay	6 months
Intraventricular hemorrhage	6 months
Number and volume of blood transfusions	10 units
duration of phototherapy	1 month

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States