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Sponsors and Collaborators: |
University of California, Davis Thrasher Research Fund Mexican National Institute of Public Health Instituto Mexicano del Seguro Social U.S. Fulbright Program |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00298051 |
The aim of the study was to determine whether delayed umbilical cord clamping, as compared to early umbilical cord clamping, improves infant iron status at 6 months of age.
Condition | Intervention | Phase |
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Iron-Deficiency Anemia |
Procedure: Delayed umbilical cord clamping |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Umbilical Cord Clamping and Infant Iron Status |
Estimated Enrollment: | 476 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | February 2005 |
In developing countries, up to 50% of children become anemic by 12 months of age. Risk factors for iron deficiency (ID) include low birth weight, maternal prenatal ID, and male sex. Iron deficiency anemia (IDA) during infancy and childhood is of particular concern because of the potentially detrimental effects on development, some of which may be irreversible even after treatment to correct the deficiency. Delayed umbilical cord clamping is an intervention that increases the infant's iron endowment at birth and has been shown to increase hemoglobin (Hgb) concentration at two months of age. We determined whether a two-minute delay in the clamping of the umbilical cord of normal-weight, full-term infants significantly affected infant iron and hematological status through 6 months of age. In addition, we determined whether the effect of delayed cord clamping was significantly enhanced in subgroups of infants at higher risk of developing iron deficiency.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Mexico, Distrito Federal | |
Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social | |
Mexico City, Distrito Federal, Mexico, 01090 |
Principal Investigator: | Kathryn G Dewey, PhD | University of California, Davis |
Principal Investigator: | Lynnette M Neufeld, PhD | Mexican National Institute of Public Health |
Study ID Numbers: | 02817-8 |
Study First Received: | February 28, 2006 |
Last Updated: | July 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00298051 |
Health Authority: | United States: Institutional Review Board; Mexico: National Institute of Public Health, Health Secretariat; Mexico: Mexican Institute of Social Security |
Iron-deficiency anemia Umbilical cord clamping Infant |
Metabolic Diseases Malnutrition Hematologic Diseases Anemia Nutrition Disorders |
Iron Metabolism Disorders Metabolic disorder Iron Deficiency Diseases Anemia, Iron-Deficiency |
Anemia, Hypochromic |