Trial record 3 of 5 for:
"Brainstem auditory evoked responses"
Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn
This study has been completed.
University of Rochester
Information provided by (Responsible Party):
First received: November 24, 2009
Last updated: March 19, 2014
Last verified: March 2014
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn
Primary Outcome Measures:
- Auditory Brainstem Responses (ABR) in Infant [ Time Frame: within 24-48 h of birth ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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 ]
At delivery a 15 mL maternal blood sample, 20 ml cord blood sample and the placenta are collected.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||up to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Pregnant adolescents in Rochester, NY.
- 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).
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01019902
|Rochester, New York, United States, 14642 |
University of Rochester
||Kimberly O'Brien, PhD
||Ronnie Guillet, MD, PhD
||University of Rochester
No publications provided by Cornell University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 24, 2009
||March 19, 2014
||United States: Institutional Review Board
Keywords provided by Cornell University:
auditory brainstem responses
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Physiological Effects of Drugs