Impact of Maternal Iron Status on Neonatal Iron Status an... | NCT01019902

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

NCT01019902

Sponsor

Cornell University

Status

Completed

Last Update Posted

Mar 20, 2014Estimated

Enrollment

144Actual

Phase

Not provided

Conditions

Anemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-01857	Other Grant/Funding Number	NRI

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Nov 2012Actual

Completion Date

Oct 2013Actual

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2014

Last Update Posted Date

Mar 20, 2014Estimated

Name	Class
University of Rochester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

144Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Auditory Brainstem Responses (ABR) in Infant		within 24-48 h of birth

Secondary Outcomes

Measure	Description	Time 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 status

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pregnant adolescents in Rochester, NY.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Kimberly O'Brien, PhD	Cornell University	Principal Investigator
Ronnie Guillet, MD, PhD	University of Rochester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Highland Hospital		Rochester	New York	14642	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37890671	Derived	Barad A, Guillet R, Pressman EK, Katzman PJ, Ganz T, Nemeth E, O'Brien KO. Placental ferroportin protein abundance is associated with neonatal erythropoietic activity and iron status in newborns at high risk for iron deficiency and anemia. Am J Clin Nutr. 2024 Jan;119(1):76-86. doi: 10.1016/j.ajcnut.2023.10.022. Epub 2023 Oct 27.
37253412

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases