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

The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants

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.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19717
      • University of Delaware: Infant Motor Beahvior Lab
    • Newark, Delaware, United States, 19718
      • Christiana Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pre-Term; Infants born pre-term with birthweight less than 1KG
Full-Term Infants; Well infants who are born full-term

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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. MRI / MRS (magnetic resonance spectroscopy) of the brain was performed as close to term equivalent age as possible.	24 months.

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: University of Delaware
• Investigators: Principal Investigator: David A. Paul, MD, Christiana Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 16, 2008

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: MRI; pre-term infants; full-term infants; brain structure development; pre term; full term
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: CCC27122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No