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

Completed

• Conditions: Anemia

• Registration Number: NCT01019902
• Lead Sponsor: Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2012-11
• Study Completion: 2013-10
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Auditory Brainstem Responses (ABR) in Infant	within 24-48 h of birth

Secondary Outcome Measures

Name	Time	Method
Neonatal Fe and micronutrient status	Delivery
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
Placental Fe/copper/zinc content and expression of key iron transporters.	Delivery

Trial Locations

Locations (1)

Highland Hospital; 🇺🇸 Rochester, New York, United States