Delayed Cord Clamping in VLBW Infants

Phase 1

Completed

• Conditions: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature
• Interventions: Procedure: Standard Cord Clamping; Procedure: Delayed Cord Clamping

• Registration Number: NCT01222364
• Lead Sponsor: NICHD Neonatal Research Network

Brief Summary

This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

Detailed Description

This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.

This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2000-12
• Study Completion: 2000-12
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-18
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Infants born at participating centers at 24-27 weeks gestation
• Singletons
• Obstetrician approval for enrollment
• Parental consent

Exclusion Criteria

• Prenatally diagnosed major congenital anomalies
• Intent to withhold or withdraw care
• Significant bleeding due to placenta previa or abruption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Cord Clamping	Standard Cord Clamping	-
Delayed Cord Clamping	Delayed Cord Clamping	-

Primary Outcome Measures

Name	Time	Method
Infants enrolled	6 months	Number of infants enrolled in the pilot within 6 months.

Secondary Outcome Measures

Name	Time	Method
Use of volume expansion or pressor therapy	24 hours of age
Blood transfusions	Until hospital discharge or 120 days of life
Intention to treat	6 months	Identify obstetricians willing to participate in randomizing subjects.
Hematocrit level	4 hours of age
Arterial blood pressure	12 hours of age

Trial Locations

Locations (4)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Brown University, Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States