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Premature BirthNCT00358891

Follow-Up of VLBW Infants With Chronic Lung Disease: Respiratory Health and Neurodevelopment

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Although previous studies showed that preterm infants resolving from neonatal respiratory disease are more likely to exhibit respiratory illness, developmental disorders, impaired growth and cognitive limitations compared with those without, the information concerning the longitudinal respiratory and… Read more about this study

Who is it for?
Ages 0 to 3 years
Conditions the study is for
Premature Birth
How many people
98 participants
Where
1 siteTaiwan
Study dates
Aug 2006to Jul 2009
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 to 3 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • BW below 1,500 gm
  • GA under 34 weeks
  • Admission to the NTUH and MMH within the first 7 days

Who cannot join

  • Existence of congenital anomalies and genetic disease

Trial locations and contacts

1 site in 1 country.

Suh-Fang Jeng, Sc.D contact

886-2-33228132

jeng@ntu.edu.tw

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 100

    Suh-Fang Jeng, Sc.D, 886-2-33228132, jeng@ntu.edu.tw

Other trials in Taiwan

About this study

Official title: Follow-Up of Very Low Birth Weight Preterm Infants With Chronic Lung Disease at Preschool Ages: Respiratory Health and Neurodevelopment

Although previous studies showed that preterm infants resolving from neonatal respiratory disease are more likely to exhibit respiratory illness, developmental disorders, impaired growth and cognitive limitations compared with those without, the information concerning the longitudinal respiratory and neurodevelopmental outcome of recently survived preterm infants with CLD is limited.Therefore, the purpose of this study is threefold. First, VLBW infants with CLD, VLBW infants without CLD and full-term infants will be examined for respiratory health at 3-5 years old and will be assessed the relations of early respiratory and environmental variables with later respiratory outcome. Secondly, all infants will be examined for neurodevelopmental outcome, and will be assessed the relations of early neuromotor and environmental variables with later neurodevelopmental outcome. Thirdly, the VLBW infants will be assessed for the concurrent and consecutive longitudinal relationships between respiratory and neurodevelopmental measures.

Read the detailed description

The introduction of antenatal steroid use, postnatal surfactant administration and modern respiratory care in the past decade has markedly improved the survival of small preterm infants. However, this has been offset by an increasing incidence of chronic lung disease CLD) as defined by oxygen requirement at 36 weeks post-conceptional age. Although previous studies showed that preterm infants resolving from neonatal respiratory disease are more likely to exhibit respiratory illness, developmental disorders, impaired growth and cognitive limitations compared with those without, the information concerning the longitudinal respiratory and neurodevelopmental outcome of recently survived preterm infants with CLD is limited. Therefore, this prospective three-year two-centered study will continue following up the respiratory health and neurodevelopment of our 73 very low birth weight (VLBW) preterm infants at preschool ages. This cohort consists of 44 infants with CLD and 29 demographically matched infants without CLD who were enrolled from the National Taiwan University Hospital and the MacKay Memorial Hospital. Those infants had been comprehensively examined for their respiratory function and neurodevelopmental performance during the neonatal and infant periods. Twenty five age-matched full-term infants will be additional included to serve as the normal reference group. The purpose of this study is threefold. First, VLBW infants with CLD, VLBW infants without CLD and full-term infants will be examined for respiratory health using pulmonary function and exercise test at 3-5 years old and will be assessed the relations of early respiratory and environmental variables with later respiratory outcome. Secondly, all infants will be examined for neurodevelopmental outcome using the Bayley Scales of Infant Development- 2nd edition, Developmental Test of Visual Motor Integration, Peabody Developmental Motor Scale- 2nd edition, Child Behavior Check List, Weschler Preschooler Intelligence Scale and clinical diagnosis by a pediatric neurologist and a pediatric psychiatrist, and will be assessed the relations of early neuromotor and environmental variables with later neurodevelopmental outcome. Thirdly, the VLBW infants will be assessed for the concurrent and consecutive longitudinal relationships between respiratory and neurodevelopmental measures. The results of this study will help understand the nature and changes of respiratory health and neurodevelopment of VLBW infants with CLD from birth to preschool age. The identified influencing factors for adverse respiratory and neurodevelopmental outcome will assist health professionals in designing treatment strategies to improve their outcome. Furthermore, the obtained database will help develop a national monitoring system for measuring effects of respiratory management and early intervention programs for preterm infants with neonatal respiratory disease.

Conditions
Premature Birth
Keywords
Prematurity, Chronic Lung Disease, Respiratory Health, Neurodevelopment, Preschool, Influencing Factors
Medical subject headings
Premature Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Study completionJul 2009

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
Case-control
Time perspective
Prospective
Enrolment
98 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00358891
Sponsor's protocol ID
9461701282
Status last verified
Jul 2006
First submitted
30 Jul 2006
Last updated
2 Aug 2006
Results posted
No

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: status not confirmed, as of the sponsor's last update on 2 Aug 2006. 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?

Results are not available in the source record.

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

Contact Suh-Fang Jeng, Sc.D (886-2-33228132, jeng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00358891, 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 2 Aug 2006.

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