Brain Structure and Development in Pre-Term and Full-Term Infants

NCT ID: NCT00679471

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Term

Infants born pre-term with birthweight less than 1KG

No interventions assigned to this group

Full-Term Infants

Well infants who are born full-term

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pre-term infants (\< 1 Kg Birthweight)
* Full-term infants (well)
Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Delaware

OTHER

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David A. Paul, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

Locations

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University of Delaware: Infant Motor Beahvior Lab

Newark, Delaware, United States

Site Status

Christiana Hospital

Newark, Delaware, United States

Site Status

Countries

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United States

References

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Gadin E, Lobo M, Paul DA, Sem K, Steiner KV, Mackley A, Anzilotti K, Galloway C. Volumetric MRI and MRS and early motor development of infants born preterm. Pediatr Phys Ther. 2012 Spring;24(1):38-44. doi: 10.1097/PEP.0b013e31823e069d.

Reference Type DERIVED
PMID: 22207464 (View on PubMed)

Other Identifiers

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CCC27122

Identifier Type: -

Identifier Source: org_study_id

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