Delayed Cord Clamping in Very Low Birth Weight Infants (DCC)

The University of Chicago

Status: Terminated

Conditions: Intraventricular Hemorrhage; Premature Infants; Very Low Birth Weight Infants

Treatments: Procedure: Delayed cord clamping at 30 seconds; Procedure: Delayed cord clamping at 60 seconds

Study type: Interventional

Funder types: Other

Identifiers

NCT02337088

14-0546

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 39 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

30 seconds

Active Comparator group

Description:

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

Treatment:

Procedure: Delayed cord clamping at 30 seconds

60 seconds

Experimental group

Description:

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

Treatment:

Procedure: Delayed cord clamping at 60 seconds