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Completed

NCT Number: NCT00679471

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

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Key information

Conditions

Healthy Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 30 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Hospital, Newark, Delaware, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

    Time frame: 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 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.

    Time frame: 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 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • University of Delaware

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 16, 2008
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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