Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354783
Recruitment Status : Unknown
Verified July 2006 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2006
Last Update Posted : July 20, 2006
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
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 or disease
Premature Birth

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.

Layout table for study information
Study Type : Observational
Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : January 2007
Study Completion Date : December 2007




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BW below 1500 gm
  • GA under 37 weeks

Exclusion Criteria:

  • Existence of congenital anomalies and genetic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354783


Contacts
Layout table for location contacts
Contact: Pei-Shan Chen 886-2-27785715 gad657@ms15.hinet.net

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Study Director: Suh-Fang Jeng, Sc.D National Taiwan University
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00354783    
Other Study ID Numbers: 9361701209
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: July 20, 2006
Last Verified: July 2006
Keywords provided by National Taiwan University Hospital:
Very low birth weight premature infants
Kicking
Stepping
Walking
Motor development
Kinematics
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications