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Infant Brain Study Follow-Up at 3 and 4 Years of Age

NCT02619006 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2018-10-15

No results posted yet for this study

Summary

When immediate clamping of the umbilical cord (ICC) occurs at birth, 20 to 30% of the fetal-placental blood volume is left behind in the placenta. Preliminary results from our current study comparing effects of ICC versus placental transfusion from delayed cord clamping (DCC) show that infants who have DCC have higher ferritin levels at 4 months of age and more myelin in important regions of the brain. Our objective for this follow-up study is to see if the effects of placental transfusion persist to three and four years of age. The investigators plan to enroll only children who participated in the previous trial (Infant Brain Study/NCT01620008) at birth for assessments at three and four years of age. Assessments include MRIs and neurodevelopmental testing to examine cognitive, motor, visual, and behavioral outcomes.

The proposed research addresses two central questions regarding the potential benefits of DCC on brain myelin development in children who were born healthy at term: 1. Does DCC result in increased brain myelin deposition at three and four years of age? and 2) Are DCC, iron stores, and brain myelin content in infancy associated with improved cognitive, motor, and socio-behavioral outcomes at three and four years of age?

Conditions

Interventions

OTHER

Delayed Cord Clamping or Cord Milking

Healthy term infants who were previously randomized or assigned at birth to the intervention group known as delayed cord clamping. The cord was clamped and cut at or beyond 300 seconds (5 mins). Cord milking (cord milked x 5) was used as a proxy for delayed cord clamping when there was a clinical situation of concern.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • University of Rhode Island

    lead OTHER

Principal Investigators

  • Judith S Mercer, PhD · University of Rhode Island, Women and Infants Hospital of Rhode Island

  • Debra A Erickson-Owens, PhD · University of Rhode Island, Women and Infants Hospital of Rhode Island

  • Sean Deoni, PhD · Brown University

Eligibility

Min Age
30 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2017-01-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02619006 on ClinicalTrials.gov