Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn
Completed
Conditions studied: Anemia
In brief
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.
Key facts
- Study ID
- NCT01019902
- Run by
- Cornell University
- People needed
- 144
- Starts
- 2008-10-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2014-03-20
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Highland Hospital — Rochester, New York, United States
Full record on ClinicalTrials.gov
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