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Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking
This study is not yet open for participant recruitment.
Verified by National Taiwan University Hospital, July 2006
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00354783
  Purpose

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.


Condition
Premature Birth

MedlinePlus related topics: Premature Babies
U.S. FDA Resources
Study Type: Observational
Study Design: Psychosocial, Longitudinal, Case Control, Prospective Study

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 15
Study Start Date: January 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BW below 1500 gm
  • GA under 37 weeks

Exclusion Criteria:

  • Existence of congenital anomalies and genetic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354783

Contacts
Contact: Pei-Shan Chen 886-2-27785715 gad657@ms15.hinet.net

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Suh-Fang Jeng, Sc.D National Taiwan University
  More Information

Study ID Numbers: 9361701209
Study First Received: July 18, 2006
Last Updated: July 18, 2006
ClinicalTrials.gov Identifier: NCT00354783  
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Very low birth weight premature infants
Kicking
Stepping
Walking
Motor development
Kinematics

Study placed in the following topic categories:
Body Weight
Birth Weight
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 14, 2009