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Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study

Primary Purpose

Iron Deficiency, Anemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
perineum maintained
abdominal placement
Sponsored by
Davison, James, D.O.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency focused on measuring iron stores, anemia, iron deficiency, infancy, placental transfusion, iron deficiency in infancy, anemia in infancy, placement of neonate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy pregnant women
  • 37 - 42 weeks of gestation
  • vaginal delivery
  • prenatal care initiated prior to 20 weeks of gestation

Exclusion Criteria:

  • maternal diabetes
  • intrauterine growth restriction
  • hypertensive disorders of pregnancy
  • chronic hypertension requiring medical therapy
  • Apgar score less than 7 at 5 minutes
  • unusual bleeding prior to delivery
  • alloimmunization
  • maternal hemoglobinopathy
  • need for immediate infant resuscitation preventing adherence to protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    perineum

    abdomen

    Arm Description

    infants maintained at the level of the perineum until umbilical cord clamping

    infants placed on the maternal abdomen prior to cord clamping

    Outcomes

    Primary Outcome Measures

    serum ferritin level at 4 months of age

    Secondary Outcome Measures

    blood parameters (hemoglobin and hematocrit)
    serum ferritin at 2 months
    blood parameters (hemoglobin and hematocrit) at 24 hrs of age

    Full Information

    First Posted
    May 7, 2008
    Last Updated
    December 30, 2008
    Sponsor
    Davison, James, D.O.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00675337
    Brief Title
    Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study
    Official Title
    The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    April 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Davison, James, D.O.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency, Anemia
    Keywords
    iron stores, anemia, iron deficiency, infancy, placental transfusion, iron deficiency in infancy, anemia in infancy, placement of neonate

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    perineum
    Arm Type
    Active Comparator
    Arm Description
    infants maintained at the level of the perineum until umbilical cord clamping
    Arm Title
    abdomen
    Arm Type
    Experimental
    Arm Description
    infants placed on the maternal abdomen prior to cord clamping
    Intervention Type
    Procedure
    Intervention Name(s)
    perineum maintained
    Intervention Description
    infants maintained at the level of the perineum until umbilical cord clamping
    Intervention Type
    Procedure
    Intervention Name(s)
    abdominal placement
    Intervention Description
    infants placed on the maternal abdomen prior to umbilical cord clamping
    Primary Outcome Measure Information:
    Title
    serum ferritin level at 4 months of age
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    blood parameters (hemoglobin and hematocrit)
    Time Frame
    2 months and 4 months
    Title
    serum ferritin at 2 months
    Time Frame
    2 months
    Title
    blood parameters (hemoglobin and hematocrit) at 24 hrs of age
    Time Frame
    24 hrs.

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy pregnant women 37 - 42 weeks of gestation vaginal delivery prenatal care initiated prior to 20 weeks of gestation Exclusion Criteria: maternal diabetes intrauterine growth restriction hypertensive disorders of pregnancy chronic hypertension requiring medical therapy Apgar score less than 7 at 5 minutes unusual bleeding prior to delivery alloimmunization maternal hemoglobinopathy need for immediate infant resuscitation preventing adherence to protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James M Davison, DO
    Organizational Affiliation
    Warren General Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sunny A Thomas, MD
    Organizational Affiliation
    Warren General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16770951
    Citation
    Lozoff B, Beard J, Connor J, Barbara F, Georgieff M, Schallert T. Long-lasting neural and behavioral effects of iron deficiency in infancy. Nutr Rev. 2006 May;64(5 Pt 2):S34-43; discussion S72-91. doi: 10.1301/nr.2006.may.s34-s43.
    Results Reference
    background
    PubMed Identifier
    17101454
    Citation
    Lozoff B, Georgieff MK. Iron deficiency and brain development. Semin Pediatr Neurol. 2006 Sep;13(3):158-65. doi: 10.1016/j.spen.2006.08.004.
    Results Reference
    background
    PubMed Identifier
    17635678
    Citation
    Grant CC, Wall CR, Brewster D, Nicholson R, Whitehall J, Super L, Pitcher L. Policy statement on iron deficiency in pre-school-aged children. J Paediatr Child Health. 2007 Jul-Aug;43(7-8):513-21. doi: 10.1111/j.1440-1754.2007.01128.x.
    Results Reference
    background
    PubMed Identifier
    17237340
    Citation
    Beard J. Recent evidence from human and animal studies regarding iron status and infant development. J Nutr. 2007 Feb;137(2):524S-530S. doi: 10.1093/jn/137.2.524S.
    Results Reference
    background
    PubMed Identifier
    17413089
    Citation
    McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007 Apr;85(4):931-45. doi: 10.1093/ajcn/85.4.931.
    Results Reference
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    PubMed Identifier
    17671043
    Citation
    Burden MJ, Westerlund AJ, Armony-Sivan R, Nelson CA, Jacobson SW, Lozoff B, Angelilli ML, Jacobson JL. An event-related potential study of attention and recognition memory in infants with iron-deficiency anemia. Pediatrics. 2007 Aug;120(2):e336-45. doi: 10.1542/peds.2006-2525.
    Results Reference
    background
    PubMed Identifier
    17016952
    Citation
    Walter T. Effect of iron-deficiency anemia on cognitive skills and neuromaturation in infancy and childhood. Food Nutr Bull. 2003 Dec;24(4 Suppl):S104-10. doi: 10.1177/15648265030244S207.
    Results Reference
    background
    PubMed Identifier
    16856818
    Citation
    Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7. doi: 10.1515/JPM.2006.056.
    Results Reference
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    PubMed Identifier
    16567393
    Citation
    Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
    Results Reference
    background
    PubMed Identifier
    17374818
    Citation
    Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
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    PubMed Identifier
    4184835
    Citation
    Yao AC, Lind J. Effect of gravity on placental transfusion. Lancet. 1969 Sep 6;2(7619):505-8. doi: 10.1016/s0140-6736(69)90213-x. No abstract available.
    Results Reference
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    PubMed Identifier
    10329884
    Citation
    Grisaru D, Deutsch V, Pick M, Fait G, Lessing JB, Dollberg S, Eldor A. Placing the newborn on the maternal abdomen after delivery increases the volume and CD34 cell content in the umbilical cord blood collected: an old maneuver with new applications. Am J Obstet Gynecol. 1999 May;180(5):1240-3. doi: 10.1016/s0002-9378(99)70623-x.
    Results Reference
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    PubMed Identifier
    11843888
    Citation
    Pafumi C, Zizza G, Russo A, Farina M, Pernicone G, Bandiera S, Giardina P, Mangiafico L, Mancari R, Maggi I, Calogero AE, Cianci A. Placing the newborn on the maternal abdomen increases the volume of umbilical cord blood collected. Clin Lab Haematol. 2001 Dec;23(6):397-9. doi: 10.1046/j.1365-2257.2001.00377.x.
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    PubMed Identifier
    4588934
    Citation
    Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. doi: 10.1001/archpedi.1974.02110200130021. No abstract available.
    Results Reference
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    PubMed Identifier
    10772736
    Citation
    Mercer JS, Nelson CC, Skovgaard RL. Umbilical cord clamping: beliefs and practices of American nurse-midwives. J Midwifery Womens Health. 2000 Jan-Feb;45(1):58-66. doi: 10.1016/s1526-9523(99)00004-5.
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    PubMed Identifier
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    Citation
    Siddappa AM, Rao R, Long JD, Widness JA, Georgieff MK. The assessment of newborn iron stores at birth: a review of the literature and standards for ferritin concentrations. Neonatology. 2007;92(2):73-82. doi: 10.1159/000100805. Epub 2007 Mar 14.
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    PubMed Identifier
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    Citation
    Beard JL, Murray-Kolb LE, Rosales FJ, Solomons NW, Angelilli ML. Interpretation of serum ferritin concentrations as indicators of total-body iron stores in survey populations: the role of biomarkers for the acute phase response. Am J Clin Nutr. 2006 Dec;84(6):1498-505. doi: 10.1093/ajcn/84.6.1498.
    Results Reference
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    Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study

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