Neural Development and Its Influencing Factors in Premature Infants With Chronic Lung Disease

March 29, 2010 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

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 12,18 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 physician's neurological diagnosis. Thirdly, 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. 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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Existence of congenital anomalies and genetic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9100208567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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