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

Anemia Clinical Trial

Official title:

The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00675337
• Other study ID #: wghjmd1
• Status: Active, not recruiting
• Phase: N/A
• First received: May 7, 2008
• Last updated: December 30, 2008
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2008
• Source: Davison, James, D.O.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Davison, James, D.O.

References & Publications (17)

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

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. — View 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. Review. — View 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. — View 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. Review. — View Citation

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

Lozoff B, Georgieff MK. Iron deficiency and brain development. Semin Pediatr Neurol. 2006 Sep;13(3):158-65. Review. — View 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. Review. — View 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. — View 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. — View 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. Epub 2007 Mar 14. Review. — View 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. Review. — View Citation

Yao AC, Lind J. Effect of gravity on placental transfusion. Lancet. 1969 Sep 6;2(7619):505-8. — View Citation

Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum ferritin level at 4 months of age		4 months	Yes
Secondary	blood parameters (hemoglobin and hematocrit)		2 months and 4 months	Yes
Secondary	serum ferritin at 2 months		2 months	Yes
Secondary	blood parameters (hemoglobin and hematocrit) at 24 hrs of age		24 hrs.	Yes