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Sponsored by: |
Davison, James, D.O. |
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Information provided by: | Davison, James, D.O. |
ClinicalTrials.gov Identifier: | NCT00675337 |
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.
Condition | Intervention |
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Iron Deficiency Anemia |
Procedure: perineum maintained Procedure: abdominal placement |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety Study |
Official Title: | The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | April 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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perineum: Active Comparator
infants maintained at the level of the perineum until umbilical cord clamping
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Procedure: perineum maintained
infants maintained at the level of the perineum until umbilical cord clamping
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abdomen: Experimental
infants placed on the maternal abdomen prior to cord clamping
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Procedure: abdominal placement
infants placed on the maternal abdomen prior to umbilical cord clamping
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Warren General Hospital ( James M. Davison, DO ) |
Study ID Numbers: | wghjmd1 |
Study First Received: | May 7, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00675337 History of Changes |
Health Authority: | United States: Institutional Review Board |
iron stores anemia iron deficiency infancy |
placental transfusion iron deficiency in infancy anemia in infancy placement of neonate |
Metabolic Diseases Hematologic Diseases Anemia Iron Metabolism Disorders |
Iron Metabolic Disorder Anemia, Iron-Deficiency |
Metabolic Diseases Hematologic Diseases Anemia, Hypochromic |
Anemia Iron Metabolism Disorders Anemia, Iron-Deficiency |