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Premature BirthNCT00155831

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

An observational study of Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 7 days
Conditions the study is for
Premature Birth
How many people
120 participants
Where
1 siteTaiwan
Study dates
Aug 2003to Mar 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 Up to 7 days
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • Existence of congenital anomalies and genetic disease

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Premature Birth
Keywords
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.

  1. First posted12 Sep 2005 (estimated)
  2. Study startAug 2003
  3. Primary completionMar 2005
  4. Study completionMar 2007

Resources

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
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00155831
Sponsor's protocol ID
9100208567
Status last verified
Mar 2010
First submitted
9 Sep 2005
Last updated
31 Mar 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35921693

Questions about this trial

What is this clinical trial studying?

An observational study of Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.

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 3 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: finished, as of the sponsor's last update on 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00155831, which also lists 1 linked publication.

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 31 Mar 2010.

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