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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
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief 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.

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

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Delivery room temperature [ Time Frame: Delivery ]
    Neonates will be assessed for hypothermia at the time of delivery.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02337088     History of Changes
Other Study ID Numbers: 14-0546
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by University of Chicago:
delayed cord clamping

Additional relevant MeSH terms:
Body Weight
Hemorrhage
Birth Weight
Cerebral Hemorrhage
Signs and Symptoms
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases