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

Premature Birth Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00354783
• Other study ID #: 9361701209
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2006
• Last updated: July 18, 2006
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: July 2006
• Source: National Taiwan University Hospital
• Contact: Pei-Shan Chen
• Phone: 886-2-27785715
• Email: gad657[@]ms15.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

Inclusion Criteria:

• BW below 1500 gm

• GA under 37 weeks

Exclusion Criteria:

• Existence of congenital anomalies and genetic disease

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital