Delayed Cord Clamping in Very Low Birth Weight Infants (DCC)
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|ClinicalTrials.gov Identifier: NCT02337088|
Recruitment Status : Terminated (Logistical reasons)
First Posted : January 13, 2015
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Very Low Birth Weight Infants Premature Infants Intraventricular Hemorrhage||Procedure: Delayed cord clamping at 30 seconds Procedure: Delayed cord clamping at 60 seconds||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial|
|Actual Study Start Date :||April 16, 2015|
|Actual Primary Completion Date :||May 17, 2017|
|Actual Study Completion Date :||August 28, 2017|
Active Comparator: 30 seconds
For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.
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
Experimental: 60 seconds
For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.
Procedure: 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
- Intraventricular hemorrhage [ Time Frame: During NICU admission up to 6 months ]Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
- Hemoglobin and hematocrit [ Time Frame: During NICU admission up to 6 months ]Neonates will be followed for up to 6-months and initial H/H will be recorded.
- Need for blood transfusion [ Time Frame: During NICU admission up to 6 months ]Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.
- Bilirubin levels [ Time Frame: During NICU admission up to 6 months ]Neonates will be followed for up to 6-months and assessed for clinical jaundice.
- Delivery room temperature [ Time Frame: Delivery ]Neonates will be assessed for hypothermia at the time of delivery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337088
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|