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Delayed Cord Clamping and Infant Brain Study (IBS)

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ClinicalTrials.gov Identifier: NCT01620008
Recruitment Status : Active, not recruiting
First Posted : June 15, 2012
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Women and Infants Hospital of Rhode Island
Brown University
Information provided by (Responsible Party):
Judith S Mercer, University of Rhode Island

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE October 1, 2012
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
Brain Myelin Volume [ Time Frame: 4 months of age ]
At 4 months of age, term infants exposed to delayed cord clamping will have greater myelin content when compared to infants exposed to immediate cord clamping
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
Ferritin levels [ Time Frame: 4 months of age ]
Term infants exposed to delayed cord clamping will have higher ferritin levels when compared to infants with immediate cord clamping.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delayed Cord Clamping and Infant Brain Study
Official Title  ICMJE Effects of Placental Transfusion on Early Brain Development
Brief Summary The purpose of this study is to determine if delaying cord clamping at the birth of term infants effects the early brain development (myelin deposition)as determined by quantitative MRI at 4 and 10 months and developmental testing at 4, 10 and 24 months. This study will help to establish a scientific basis for the timing of cord clamping with reference to brain development.
Detailed Description

The current obstetrical practice at birth in the United States is that the umbilical cord of the infant is clamped immediately. When immediate clamping occurs, 20 to 40% of the fetal-placental blood volume is left behind in the placenta. This blood contains enough iron-rich red blood cells to meet the infant's iron needs for the first 4 to 6 months of life. Delaying cord clamping has been shown to increase early iron stores without contributing to adverse outcomes. Early iron sufficiency is essential for long term neurologic health. Iron deficiency in infancy adversely affects cognitive, motor, socio-emotional, and behavioral development. Human and animal studies have shown that inadequate iron stores in early infancy have an irreversible negative impact on the developing brain with deficits persisting even after iron levels have been restored by iron supplementation. Iron is an essential component of myelination which is critical for normal brain development and function. Myelination, which peaks during the first year of life, establishes and maintains efficient communication between the discrete regions of the brain. Abnormal myelination underlies a variety of childhood developmental disorders including conditions such as autism.

The gap is that the effect of increased iron stores from delayed cord clamping on myelination and neurodevelopment during early childhood is unknown. Our hypothesis is that placental transfusion affects myelination and early childhood development in the following ways: 1) placental transfusions lead to increased blood volume (BV) and red cell volume (RCV) at birth; 2) increased RCV results in more available iron for early body iron stores; 3) increased body iron stores provide essential iron supply for optimal myelination; 4) optimal myelination results in improved developmental and cognitive performance. We propose a randomized controlled longitudinal (birth to 24 months) trial of 128 infants to measure the effect of placental transfusion on the structure and function of the developing brain. We will use a non-invasive neuroimaging technique to measure myelin acquisition over time and to correlate the findings with iron stores and developmental outcomes. Enrolled women will be randomized at birth to the immediate cord clamping group or the delayed cord clamping group. We will assess infants for iron sufficiency and myelin deposition at 4 and 10 months and evaluate developmental outcomes at 4, 10, and 24 months. This study will help to establish a scientific basis for the timing of cord clamping with reference to brain development. The innovation of this study is in the simplicity of delaying cord clamping combined with the use of a new method of MRI that can quantify myelin deposition. This low-tech change in a clinical practice has the potential to reduce iron deficiency and improve developmental outcomes. If delayed cord clamping demonstrates protective effects for optimal development, changing practice will translate into a large cost savings improving lifetime productivity beneficial to society as a whole.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized trial (with a preference arm)
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Iron Deficiency
Intervention  ICMJE Procedure: Delayed Cord Clamping
At birth, the infant will be placed on the maternal abdomen and the umbilical will either be cut immediately or after a 5 minute delay.
Other Name: delayed umbilical cord clamping
Study Arms  ICMJE
  • No Intervention: Immediate Cord Clamping (ICC)
    The infant will be placed on the maternal abdomen and the umbilical cord will be clamped immediately after birth (routine care).
  • Experimental: Delayed Cord Clamping (DCC)
    At birth, infants will be placed on the maternal abdomen and the cord clamping will be delayed for 5 minutes. If the provider is unable to delay the cord clamping, the cord will be milked 5 times.
    Intervention: Procedure: Delayed Cord Clamping
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 24, 2017)
106
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
24
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women in the third trimester with:
  • singleton pregnancy
  • planning to breastfeed for six months
  • English speaking
  • planning vaginal birth

Exclusion Criteria:

  • major medical or obstetrical complications
  • Intrauterine growth restriction
  • chorioamnionitis
  • familial learning disability
  • major psychiatric or depressive illness
  • fetal congenital anomalies
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620008
Other Study ID Numbers  ICMJE Mercer-9329
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Judith S Mercer, University of Rhode Island
Study Sponsor  ICMJE University of Rhode Island
Collaborators  ICMJE
  • Women and Infants Hospital of Rhode Island
  • Brown University
Investigators  ICMJE
Principal Investigator: Judith S Mercer, PhD, CNM Women & Infants Hospital of Rhode Island, University of Rhode Island
Principal Investigator: Debra A Erickson-Owens, PhD, CNM University of Rhode Island; Women & Infants Hospital of Rhode Island
Principal Investigator: Sean C. Deoni, PhD Brown University
PRS Account University of Rhode Island
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP