Delayed Cord Clamping in VLBW Infants

NICHD Neonatal Research Network

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infant, Low Birth Weight; Infant, Newborn; Infant, Small for Gestational Age; Infant, Premature

Treatments: Procedure: Delayed Cord Clamping; Procedure: Standard Cord Clamping

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01222364

M01RR000080 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

NICHD-NRN-0023

U10HD021364 (U.S. NIH Grant/Contract)

M01RR008084 (U.S. NIH Grant/Contract)

U01HD021438 (U.S. NIH Grant/Contract)

U10HD027904 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: Under 1 minute old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Standard Cord Clamping

Active Comparator group

Treatment:

Procedure: Standard Cord Clamping

Delayed Cord Clamping

Experimental group

Treatment:

Procedure: Delayed Cord Clamping