NCT00155831

Brief Summary

Current approaches to treatment of premature infants at risk for neurodevelopmental disabilities have emphasized early assessment and intervention within the first year of life to optimize their developmental outcome. However, the information concerning the course of early neuromotor development and the factors contributing to neurodevelopmental disabilities in premature infants with CLD is limited. Therefore, the major purposes of this three-year multi-centered developmental follow-up study are threefold. (1) We will prospectively evaluate the early neuromotor performance of premature infants with CLD and premature infants without CLD from birth until 12 months of corrected age. (2) We will follow up the neurodevelopmental outcome of these infants at 12,18 and 24 months of corrected age to identify the early neuromotor impairments that predict later neurodevelopmental disabilities. (3) We will examine two potential influencing factors i.e., respiratory disease itself and brain lesions that may contribute to the neurodevelopmental disabilities in premature infants with CLD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

1.6 years

First QC Date

September 9, 2005

Last Update Submit

March 29, 2010

Conditions

Keywords

Premature infantsKickingSteppingWalkingMotor developmentKinematics

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

premature infants with chronic lung disease(CLD) and 60 premature infants without CLD from National Taiwan University Hospital and MacKay Memorial Hospital

You may qualify if:

  • BW below 2,000 gm
  • GA under 34 weeks
  • Admission to the NICU within the first 7 days

You may not qualify if:

  • Existence of congenital anomalies and genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Li SJ, Tsao PN, Tu YK, Hsieh WS, Yao NJ, Wu YT, Jeng SF. Cognitive and motor development in preterm children from 6 to 36 months of age: Trajectories, risk factors and predictability. Early Hum Dev. 2022 Sep;172:105634. doi: 10.1016/j.earlhumdev.2022.105634. Epub 2022 Jul 28.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

August 1, 2003

Primary Completion

March 1, 2005

Study Completion

March 1, 2007

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations