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

NCT00675337 | Unknown DMC

• 1 other identifier: wghjmd1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency; Anemia

Keywords

iron stores; anemia; iron deficiency; infancy; placental transfusion; iron deficiency in infancy; anemia in infancy; placement of neonate

Outcome Measures

Primary Outcomes (1)

• serum ferritin level at 4 months of age

  4 months

Secondary Outcomes (3)

• blood parameters (hemoglobin and hematocrit)

  2 months and 4 months

• serum ferritin at 2 months

  2 months

• blood parameters (hemoglobin and hematocrit) at 24 hrs of age

  24 hrs.

Study Arms (2)

perineum

ACTIVE COMPARATOR

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

Procedure: perineum maintained

abdomen

EXPERIMENTAL

infants placed on the maternal abdomen prior to cord clamping

Procedure: abdominal placement

Interventions

perineum maintained PROCEDURE

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

perineum

abdominal placement PROCEDURE

infants placed on the maternal abdomen prior to umbilical cord clamping

abdomen

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Davison, James, D.O.: lead

Related Publications (17)

• 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.

  PMID: 16770951 BACKGROUND

• 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.

  PMID: 17101454 BACKGROUND

• 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.

  PMID: 17635678 BACKGROUND

• 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.

  PMID: 17237340 BACKGROUND

• 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.

  PMID: 17413089 BACKGROUND

• 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.

  PMID: 17671043 BACKGROUND

• 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.

  PMID: 17016952 BACKGROUND

• Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7. doi: 10.1515/JPM.2006.056.

  PMID: 16856818 BACKGROUND

• 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.

  PMID: 16567393 BACKGROUND

• 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.

  PMID: 17374818 BACKGROUND

• 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.

  PMID: 4184835 BACKGROUND

• 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.

  PMID: 10329884 BACKGROUND

• 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.

  PMID: 11843888 BACKGROUND

• 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.

  PMID: 4588934 BACKGROUND

• 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.

  PMID: 10772736 BACKGROUND

• 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.

  PMID: 17361090 BACKGROUND

• 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.

  PMID: 17158435 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia; Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• James M Davison, DO

  Warren General Hospital

  PRINCIPAL INVESTIGATOR

• Sunny A Thomas, MD

  Warren General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 9, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: December 31, 2008

Record last verified: 2008-12