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Infant Brain Study (IBS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Rhode Island
Sponsor:
Collaborators:
Women and Infants Hospital of Rhode Island
Brown University
Information provided by (Responsible Party):
Judith S Mercer, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01620008
First received: June 12, 2012
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Iron Deficiency
Procedure: Delayed Cord Clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Placental Transfusion on Early Brain Development

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • Brain Myelin Volume [ Time Frame: 4 months of age ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Ferritin levels [ Time Frame: 4 months of age ] [ Designated as safety issue: No ]
    Term infants exposed to delayed cord clamping will have higher ferritin levels when compared to infants with immediate cord clamping.


Estimated Enrollment: 128
Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620008

Contacts
Contact: Debra A Erickson-Owens, PhD, CNM 401-274-1100 ext 8662 debeo@uri.edu
Contact: Judith S Mercer, PhD, CNM 401-274-1100 ext 8661 jmercer@uri.edu

Locations
United States, Rhode Island
Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Manuela Barcelos, BA    401-274-1100 ext 8663    mbarcelos@wihri.org   
Principal Investigator: Debra A Erickson-Owens, PhD, CNM         
Principal Investigator: Judith Mercer, PhD, CNM         
Sponsors and Collaborators
University of Rhode Island
Women and Infants Hospital of Rhode Island
Brown University
Investigators
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
  More Information

Publications:
Responsible Party: Judith S Mercer, Principal Investigator, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01620008     History of Changes
Other Study ID Numbers: Mercer-9329
Study First Received: June 12, 2012
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
cord clamping (delayed or immediate)
Myelin content
Ferritin

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014