Delayed Cord Clamping in VLBW Infants

Infant, Premature Clinical Trial

Official title:

Delayed Cord Clamping in VLBW Infants Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222364
• Other study ID #: NICHD-NRN-0023
• Secondary ID: U10HD021364U01HD
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 14, 2010
• Last updated: September 22, 2017
• Start date: June 2000
• Est. completion date: December 2000

Study information

• Verified date: September 2017
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2000
• Est. primary completion date: December 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Infant, Low Birth Weight
• Infant, Newborn
• Infant, Premature
• Infant, Small for Gestational Age

Intervention

Procedure:
• Standard Cord Clamping
Immediate clamping (<5 seconds) of the umbilical cord after delivery.
• Delayed Cord Clamping
Clamping of the umbilical cord at 30-45 seconds after birth.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
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	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infants enrolled	Number of infants enrolled in the pilot within 6 months.	6 months
Secondary	Intention to treat	Identify obstetricians willing to participate in randomizing subjects.	6 months
Secondary	Hematocrit level		4 hours of age
Secondary	Arterial blood pressure		12 hours of age
Secondary	Use of volume expansion or pressor therapy		24 hours of age
Secondary	Blood transfusions		Until hospital discharge or 120 days of life

External Links

•   NICHD Neonatal Research Network