Delayed Cord Clamping in Very Low Birth Weight Infants

Intraventricular Hemorrhage Clinical Trial

— DCC  

Official title:

Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02337088
• Other study ID #: 14-0546
• Status: Terminated
• Phase: N/A
• First received: December 15, 2014
• Last updated: August 28, 2017
• Start date: April 16, 2015
• Est. completion date: August 28, 2017

Study information

• Verified date: August 2017
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 28, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage
• Premature Infants
• Very Low Birth Weight Infants

Intervention

Procedure:
• Delayed cord clamping at 30 seconds
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 seconds
For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraventricular hemorrhage	Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.	During NICU admission up to 6 months
Secondary	Hemoglobin and hematocrit	Neonates will be followed for up to 6-months and initial H/H will be recorded.	During NICU admission up to 6 months
Secondary	Need for blood transfusion	Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.	During NICU admission up to 6 months
Secondary	Bilirubin levels	Neonates will be followed for up to 6-months and assessed for clinical jaundice.	During NICU admission up to 6 months
Secondary	Delivery room temperature	Neonates will be assessed for hypothermia at the time of delivery.	Delivery