Brain Structure and Development in Pre-Term and Full-Term Infants
This study has been completed.
Sponsor:
Christiana Care Health Services
Collaborator:
University of Delaware
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00679471
First received: May 14, 2008
Last updated: June 3, 2013
Last verified: June 2013
| Tracking Information | |||||
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| First Received Date ICMJE | May 14, 2008 | ||||
| Last Updated Date | June 3, 2013 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00679471 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] 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. |
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| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brain Structure and Development in Pre-Term and Full-Term Infants | ||||
| Official Title ICMJE | The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 47 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 30 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00679471 | ||||
| Other Study ID Numbers ICMJE | CCC27122 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christiana Care Health Services | ||||
| Study Sponsor ICMJE | Christiana Care Health Services | ||||
| Collaborators ICMJE | University of Delaware | ||||
| Investigators ICMJE |
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| Information Provided By | Christiana Care Health Services | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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