Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155831
Status:
COMPLETED
Last Update Posted:
2010-03-31
First Post:
2005-09-09
Brief Title:
Neural Development and Its Influencing Factors in Premature Infants With Chronic Lung Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1218 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 ie respiratory disease itself and brain lesions that may contribute to the neurodevelopmental disabilities in premature infants with CLD
Detailed Description:
In the past three decades the advancement of perinatal and neonatal care has resulted in a marked improvement in the survival of premature infants However this has been offset by an increasing incidence of chronic lung disease CLD Longitudinal follow-up studies indicated that premature infants resolving from CLD have a higher risk of neurodevelopmental disabilities and have poorer cognitive performance at school age compared with those without 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 First 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 Neuromotor performance will be assessed using the Neonatal Neurobehavioral Examination- Chinese version during neonatal period and the Alberta Infant Motor Scale and a three-dimensional video motion analysis system during infancy Secondly we will follow up the neurodevelopmental outcome of these infants at 1218 and 24 months of corrected age to identify the early neuromotor impairments that predict later neurodevelopmental disabilities Neurodevelopmental outcome will be assessed using the Bayley Scale of Infant Development- 2nd edition and physicians neurological diagnosis Thirdly we will examine two potential influencing factors ie respiratory disease itself and brain lesions that may contribute to the neurodevelopmental disabilities in premature infants with CLD Respiratory disease will be assessed using the Clinical and Roentgenographic Scoring Systems for Assessing Bronchopulmonary Dysplasia during neonatal period and pulse oximeter during infancy Brain lesions will be assessed with cranial ultrasonography and magnetic resonance imaging This research project will enroll 60 premature infants with CLD and 60 premature infants without CLD from National Taiwan University Hospital and MacKay Memorial Hospital The groups will be matched for birth weight The results of this study will help understand the course and nature of early neuromotor development in premature infants with CLD The obtained early neuromotor predictors will assist clinician early detection of infants who are at greatest risk for developmental disabilities and are in most need of early intervention services The identified factors for adverse neurodevelopment in premature infants with CLD will assist health care professionals in designing prevention and intervention programs to enhance their developmental outcome Furthermore the obtained database will help develop a national monitoring system for measuring developmental effects of respiratory management and early intervention programs for premature infants with neonatal respiratory disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None