Delayed Cord Clamping in VLBW Infants

Delayed Cord Clamping in VLBW Infants Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Infant, Small for Gestational Age; Infant, Premature; Infant, Low Birth Weight; Infant, Newborn
• Intervention / Treatment: Procedure: Standard Cord Clamping; Procedure: Delayed Cord Clamping

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-7335
      • University Of Alabama
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati Children's Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Rainbow Babies and Children's Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Brown University, Women & Infants Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 minute (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Cord Clamping	Procedure: Standard Cord Clamping; Immediate clamping (<5 seconds) of the umbilical cord after delivery.
Experimental: Delayed Cord Clamping	Procedure: Delayed Cord Clamping; Clamping of the umbilical cord at 30-45 seconds after birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infants enrolled	Number of infants enrolled in the pilot within 6 months.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NICHD Neonatal Research Network
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Avroy A. Fanaroff, MD, Case Western Reserve University, Rainbow Babies and Children's Hospital

Publications and helpful links

Helpful Links

• NICHD Neonatal Research Network

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): December 1, 2000
• Study Completion (Actual): December 1, 2000

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Prematurity; NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW)
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: NICHD-NRN-0023; U10HD021364 (U.S. NIH Grant/Contract); U10HD027853 (U.S. NIH Grant/Contract); U10HD027904 (U.S. NIH Grant/Contract); M01RR008084 (U.S. NIH Grant/Contract); U01HD021438 (U.S. NIH Grant/Contract); M01RR000080 (U.S. NIH Grant/Contract)