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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01019902
Enrollment
144
Registered
2009-11-25
Start date
2008-10-31
Completion date
2013-10-31
Last updated
2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

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

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.

Interventions

None listed

Sponsors

University of Rochester
CollaboratorOTHER
Cornell University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Auditory Brainstem Responses (ABR) in Infantwithin 24-48 h of birth

Secondary

MeasureTime frame
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 statusDelivery
Placental Fe/copper/zinc content and expression of key iron transporters.Delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026