- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00354783
Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking
July 18, 2006 updated by: National Taiwan University Hospital
The purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in VLBW premature infants until attainment of independent walking; and (2) to assess factors (i.e.
gross motor development, cardiopulmonary function, anthropometry, body composition and cognition) that could potentially influence walking attainment in VLBW premature infants.
Study Overview
Status
Unknown
Conditions
Detailed Description
Very low birth weight (VLBW) preterm infants (birth weight < 1,500g) sustain a high risk of neuromotor disability, as exemplified by delayed walking attainment.
Spontaneous kicking and supported stepping have been proposed as the early precursors to independent walking.
The continuity of these early leg movements with independent walking has been established in normal term infants, but such relations remain unclear in VLBE premature infants.
Therefore, the purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in VLBW premature infants until attainment of independent walking; and (2) to assess factors (i.e.
gross motor development, cardiopulmonary function, anthropometry, body composition and cognition) that could potentially influence walking attainment in VLBW premature infants.
This study will enroll 15 VLBW premature infants born at National Taiwan University Hospital.
Infants will be scheduled for spontaneous kicking examination at 2 and 4 months of corrected age, followed by supported stepping examination at 9 and 11 months of corrected age and recorded their age of walking attainment.
Age of walking attainment is defined as the time when the child is first able to move for five successive steps without support.
At each visit, infants will be examined for spontaneous kicking or supported stepping movements (with three-dimensional kinematic analysis of Peak Motion Analysis System), gross motor function (with the Alberta Infant Motor Scale), cardiopulmonary function (with a pulsed oxymeter), anthropometry (with scale and tape measure), body composition (with the Pediatric Plicometric System) and cognition (with the Chinese Child Development Inventory- Cognitive Subscale).
The results of this study will provide important information to help reveal the maturation process of early leg movements prior to walking attainment in premature infants.
Furthermore, the identified early neuromotor markers and influencing factors for walking attainment will provide physical therapists useful guidance in making early treatment plans for those premature infants who will develop motor delays.
Study Type
Observational
Enrollment
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pei-Shan Chen
- Phone Number: 886-2-27785715
- Email: gad657@ms15.hinet.net
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BW below 1500 gm
- GA under 37 weeks
Exclusion Criteria:
- Existence of congenital anomalies and genetic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Suh-Fang Jeng, Sc.D, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion
December 1, 2007
Study Registration Dates
First Submitted
July 18, 2006
First Submitted That Met QC Criteria
July 18, 2006
First Posted (Estimate)
July 20, 2006
Study Record Updates
Last Update Posted (Estimate)
July 20, 2006
Last Update Submitted That Met QC Criteria
July 18, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9361701209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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