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

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01019902
First received: November 24, 2009
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Auditory Brainstem Responses (ABR) in Infant [ Time Frame: within 24-48 h of birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Neonatal Fe and micronutrient status [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Placental Fe/copper/zinc content and expression of key iron transporters. [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 144
Study Start Date: October 2008
Study Completion Date: October 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant adolescents in Rochester, NY.

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01019902

Locations
United States, New York
Highland Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Principal Investigator: Kimberly O'Brien, PhD Cornell University
Principal Investigator: Ronnie Guillet, MD, PhD University of Rochester
  More Information

No publications provided by Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01019902     History of Changes
Other Study ID Numbers: RSRB00024804, 2008-01857
Study First Received: November 24, 2009
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cornell University:
iron
pregnancy
adolescents
auditory brainstem responses
anemia
neonate

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014