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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019902
• Other study ID #: RSRB00024804
• Secondary ID: 2008-01857
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: March 19, 2014
• Start date: October 2008
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
United States	Highland Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory Brainstem Responses (ABR) in Infant		within 24-48 h of birth	No
Secondary	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	No
Secondary	Neonatal Fe and micronutrient status		Delivery	No
Secondary	Placental Fe/copper/zinc content and expression of key iron transporters.		Delivery	No