NCT00354783

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 20, 2006

Status Verified

July 1, 2006

First QC Date

July 18, 2006

Last Update Submit

July 18, 2006

Conditions

Premature Birth

Keywords

Very low birth weight premature infantsKickingSteppingWalkingMotor developmentKinematics

Eligibility Criteria

Age0 Years - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • BW below 1500 gm
  • GA under 37 weeks

You may not qualify if:

  • Existence of congenital anomalies and genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature BirthGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suh-Fang Jeng, Sc.D

    National Taiwan University

    STUDY DIRECTOR

Central Study Contacts

Pei-Shan Chen

CONTACT

886-2-27785715gad657@ms15.hinet.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

January 1, 2007

Study Completion

December 1, 2007

Last Updated

July 20, 2006

Record last verified: 2006-07