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

NCT01819532 | Terminated

• 1 other identifier: NA_00046760
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

neonate; umbilical cord; cord milking; prematurity

Outcome Measures

Primary Outcomes (1)

• Hemoglobin during NICU course

  within 24 hours of birth and through NICU stay

Secondary Outcomes (14)

• 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

Study Arms (2)

Immediate umbilical cord clamping

ACTIVE COMPARATOR

The umbilical cord will be clamped immediately after delivery.

Procedure: Immediate cord clamping

Cord milking group

EXPERIMENTAL

The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.

Procedure: Milking group

Interventions

Milking group PROCEDURE

The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.

Cord milking group

Immediate cord clamping PROCEDURE

The umbilical cord will be clamped and cut immediately after delivery of the neonate.

Immediate umbilical cord clamping

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jessica Bienstock, MD MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: March 27, 2013
• Study Start: September 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

US (1)