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

NCT00679471 | Completed

• 1 other identifier: CCC27122
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Keywords

pre-term infants; full-term infants; MRI; brain structure development; pre term; full term

Outcome Measures

Primary Outcomes (1)

• To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age

  To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age. This is accomplished through a series of play activities.

  6 months

Secondary Outcomes (1)

• To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age.

  6 months

Other Outcomes (1)

• To determine the ability of data from learning and coordination impairments and brain MRI / MRS (magnetic resonance spectroscopy) to predict results from common clinical assessments from 3-24 months.

  24 months.

Study Arms (2)

Pre-Term

Infants born pre-term with birthweight less than 1KG

Full-Term Infants

Well infants who are born full-term

Eligibility Criteria

• Age: Up to 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pre-term or full-term infants who are admitted to the Neonatal Intensive Care Unit (NICU) at Christiana Hospital.

You may qualify if:

• Pre-term infants (\< 1 Kg Birthweight)
• Full-term infants (well)

Sponsors & Collaborators

• Christiana Care Health Services: lead
• University of Delaware: collaborator

Study Sites (2)

University of Delaware: Infant Motor Beahvior Lab

Newark, Delaware, 19717, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Related Publications (1)

• 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.

  PMID: 22207464 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• David A. Paul, MD

  Christiana Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (2)