Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study - Full Text View

Sponsored by:	Davison, James, D.O.
Information provided by:	Davison, James, D.O.
ClinicalTrials.gov Identifier:	NCT00675337

Purpose

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
Iron Deficiency Anemia	Procedure: perineum maintained Procedure: abdominal placement

MedlinePlus related topics: Anemia

U.S. FDA Resources

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

Further study details as provided by Davison, James, D.O.:

Primary Outcome Measures:

serum ferritin level at 4 months of age [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

blood parameters (hemoglobin and hematocrit) [ Time Frame: 2 months and 4 months ] [ Designated as safety issue: Yes ]
serum ferritin at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
blood parameters (hemoglobin and hematocrit) at 24 hrs of age [ Time Frame: 24 hrs. ] [ Designated as safety issue: Yes ]

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
perineum: Active Comparator infants maintained at the level of the perineum until umbilical cord clamping	Procedure: perineum maintained infants maintained at the level of the perineum until umbilical cord clamping
abdomen: Experimental infants placed on the maternal abdomen prior to cord clamping	Procedure: abdominal placement infants placed on the maternal abdomen prior to umbilical cord clamping

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675337

Sponsors and Collaborators

Davison, James, D.O.

Investigators

Principal Investigator:	James M Davison, DO	Warren General Hospital
Principal Investigator:	Sunny A Thomas, MD	Warren General Hospital

More Information

Publications:

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. Review.

Lozoff B, Georgieff MK. Iron deficiency and brain development. Semin Pediatr Neurol. 2006 Sep;13(3):158-65. Review.

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. Review.

Beard J. Recent evidence from human and animal studies regarding iron status and infant development. J Nutr. 2007 Feb;137(2):524S-530S.

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. Review.

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.

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. Review.

Levy T, Blickstein I. Timing of cord clamping revisited. J Perinat Med. 2006;34(4):293-7. Review.

Ceriani Cernadas JM, Carroli G, Pellegrini L, Otaño L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizábal 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. Epub 2006 Mar 27.

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. Review.

Yao AC, Lind J. Effect of gravity on placental transfusion. Lancet. 1969 Sep 6;2(7619):505-8. No abstract available.

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.

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.

Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. Review. No abstract available.

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.

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. Epub 2007 Mar 14. Review.

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.

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
Health Authority:	United States: Institutional Review Board

Keywords provided by Davison, James, D.O.:

iron stores
anemia
iron deficiency
infancy

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

Study placed in the following topic categories:

Metabolic Diseases
Hematologic Diseases
Anemia
Iron Metabolism Disorders

Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Anemia, Hypochromic

ClinicalTrials.gov processed this record on January 16, 2009