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OpenTrials
Completed

NCT Number: NCT01514747

A MRI Study of Visual and Motor Pathways in Premature Infants

Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long-term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.

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Key information

Conditions

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

Age range

2 month–5 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72211, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ELBW infants with birth weight 401-1000 g (gestational age <30 weeks)

Exclusion criteria

  • Complex congenital anomalies
  • Central nervous system malformations,
  • Chromosomal abnormalities, or hydrops fetalis

Treatment and study plan

Primary outcomes

  1. MRI

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2012
Registry last updated
Jul 12, 2019

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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