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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00679471

Enrollment

Registered

2008-05-16

Start date

2007-11-30

Completion date

2011-12-31

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 30 Months

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age	6 months	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.

Secondary

Measure	Time frame	Description
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	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.

Other

Measure	Time frame	Description
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.	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.

Countries

United States

Outcome results