Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn

NCT01019902 | Completed DMC

• 2 other identifiers: RSRB000248042008-01857
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine how maternal Fe status influences placental and neonatal Fe status in pregnant adolescents and to assess the impact of the Fe endowment of birth on functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in neonates born to these adolescents.

Conditions

Anemia

Keywords

iron; pregnancy; adolescents; auditory brainstem responses; anemia; neonate

Outcome Measures

Primary Outcomes (1)

• Auditory Brainstem Responses (ABR) in Infant

  within 24-48 h of birth

Secondary Outcomes (3)

• Maternal Fe and micronutrient status (folate, B12, Fe, copper and zinc, hemoglobin, hematocrit,transferrin receptor, hepcidin, erythropoietin, ferritin, erythrocyte zinc protoporphyrin/heme ratios and c-reactive protein)

  Delivery

• Neonatal Fe and micronutrient status

  Delivery

• Placental Fe/copper/zinc content and expression of key iron transporters.

  Delivery

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant adolescents in Rochester, NY.

You may qualify if:

• Adolescents (ages 11-18 y) and their newborns will be eligible to participate if the adolescent is carrying a singleton pregnancy, does not have any preexisting medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis).

You may not qualify if:

• Individuals with pregnancy induced hypertension or elevated diastolic blood pressure (\>110) will not be eligible to participate in the study. In addition, adolescents who have been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study.
• Data from infants that experience perinatal asphyxia, pathologic neonatal hyperbilirubinemia, respiratory disease, antibiotic therapy (aminoglycosides), CNS infection, sepsis, congenital or middle or external ear lesions, craniofacial anomalies, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex infection) or those that were clinically unstable with the first 48 h post-delivery will be excluded from ABR studies. Infants born to mothers with positive drug abuse screens at delivery will also be excluded from further study (these screens are automatically run among this age group). Infants that are identified with hearing deficits at birth using the OAE screening will be excluded from the ABR measures.

Sponsors & Collaborators

• Cornell University: lead
• University of Rochester: collaborator

Study Sites (1)

Highland Hospital

Rochester, New York, 14642, United States

Location

Related Publications (6)

• Barad A, Guillet R, Pressman EK, Katzman PJ, Ganz T, Nemeth E, O'Brien KO. Placental ferroportin protein abundance is associated with neonatal erythropoietic activity and iron status in newborns at high risk for iron deficiency and anemia. Am J Clin Nutr. 2024 Jan;119(1):76-86. doi: 10.1016/j.ajcnut.2023.10.022. Epub 2023 Oct 27.

  PMID: 37890671 DERIVED

• Delaney KM, Barad A, Castillo LF, Hasund CM, Guillet R, Pressman EK, Katzman PJ, Ganz T, Nemeth E, O'Brien KO. Placental Erythroferrone and Erythropoietin mRNA Expression is not Associated with Maternal or Neonatal Iron Status in Adolescents Carrying Singletons and Adult Women Carrying Multiples. J Nutr. 2023 Jul;153(7):1950-1958. doi: 10.1016/j.tjnut.2023.05.023. Epub 2023 May 28.

  PMID: 37253412 DERIVED

• Delaney KM, Guillet R, Fleming RE, Ru Y, Pressman EK, Vermeylen F, Nemeth E, O'Brien KO. Umbilical Cord Serum Ferritin Concentration is Inversely Associated with Umbilical Cord Hemoglobin in Neonates Born to Adolescents Carrying Singletons and Women Carrying Multiples. J Nutr. 2019 Mar 1;149(3):406-415. doi: 10.1093/jn/nxy286.

  PMID: 30770543 DERIVED

• Lumish RA, Young SL, Lee S, Cooper E, Pressman E, Guillet R, O'Brien KO. Gestational iron deficiency is associated with pica behaviors in adolescents. J Nutr. 2014 Oct;144(10):1533-9. doi: 10.3945/jn.114.192070. Epub 2014 Aug 13.

  PMID: 25122650 DERIVED

• Lee S, Guillet R, Cooper EM, Westerman M, Orlando M, Pressman E, O'Brien KO. Maternal inflammation at delivery affects assessment of maternal iron status. J Nutr. 2014 Oct;144(10):1524-32. doi: 10.3945/jn.114.191445. Epub 2014 Jul 30.

  PMID: 25080540 DERIVED

• Jaacks LM, Young MF, Essley BV, McNanley TJ, Cooper EM, Pressman EK, McIntyre AW, Orlando MS, Abkowitz JL, Guillet R, O'Brien KO. Placental expression of the heme transporter, feline leukemia virus subgroup C receptor, is related to maternal iron status in pregnant adolescents. J Nutr. 2011 Jul;141(7):1267-72. doi: 10.3945/jn.110.135798. Epub 2011 May 18.

  PMID: 21593354 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

At delivery a 15 mL maternal blood sample, 20 ml cord blood sample and the placenta are collected.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kimberly O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Ronnie Guillet, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: October 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

US (1)