Delayed Cord Clamping in Very Low Birth Weight Infants

University of Chicago39 enrolled

Overview

The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.

Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood. Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping. Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Very Low Birth Weight Infants Premature Infants Intraventricular Hemorrhage

Interventions

Delayed cord clamping at 30 secondsPROCEDURE

For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery

Delayed cord clamping at 60 secondsPROCEDURE

For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women who are expected to deliver a very low birth weight infant * Neonates born weighing \>= 500g and \<1500 grams * Mother 18 years of age or older * English speaking mother Exclusion Criteria: * Placental abruption * Vasa previa * Fetal hydrops or other signs of fetal volume overload * Other major fetal anomalies * Placenta Accreta * Mother \< 18 years of age * Non-English speaking mother * Infants \>= 1500g (3.3 lbs) or \<500g

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Intraventricular hemorrhage

Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.

Time frame: During NICU admission up to 6 months

Secondary Outcomes

Hemoglobin and hematocrit

Neonates will be followed for up to 6-months and initial H/H will be recorded.

Time frame: During NICU admission up to 6 months

Need for blood transfusion

Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.

Time frame: During NICU admission up to 6 months

Bilirubin levels

Neonates will be followed for up to 6-months and assessed for clinical jaundice.

Time frame: During NICU admission up to 6 months

Delivery room temperature

Neonates will be assessed for hypothermia at the time of delivery.

Time frame: Delivery

Data from ClinicalTrials.gov

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