Premature BirthNCT00354783
Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking
An observational study of Premature Birth, run by National Taiwan University Hospital.
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. Read more about this study
- Who is it for?
- Ages 0 years to 2 months
- Conditions the study is for
- Premature Birth
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BW below 1500 gm
- GA under 37 weeks
Who cannot join
- Existence of congenital anomalies and genetic disease
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Premature Birth
- Keywords
- Very low birth weight premature infants, Kicking, Stepping, Walking, Motor development, Kinematics
- Medical subject headings
- Premature Birth, Gait Disorders, Neurologic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Suh-Fang Jeng, Sc.D, Study director, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354783
- Sponsor's protocol ID
- 9361701209
- Status last verified
- Jul 2006
- First submitted
- 18 Jul 2006
- Last updated
- 20 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking
- ClinicalTrials.gov ID
- NCT00354783
- Acronym / sponsor ID
- 9361701209
- Conditions
- Premature Birth
- Keywords
- Very low birth weight premature infants, Kicking, Stepping, Walking, Motor development, Kinematics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- BW below 1500 gm
- GA under 37 weeks
Key exclusion criteria (1 listed)
- Existence of congenital anomalies and genetic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2006.
Related trials for Premature Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suh-Fang Jeng, Sc.D study director
National Taiwan University
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Shan Chen (886-2-27785715, gad657@ms15.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2006.