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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00358891
First received: July 30, 2006
Last updated: August 1, 2006
Last verified: July 2006
  Purpose

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.


Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
Official Title: Follow-Up of Very Low Birth Weight Preterm Infants With Chronic Lung Disease at Preschool Ages: Respiratory Health and Neurodevelopment

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 98
Study Start Date: August 2006
Estimated Study Completion Date: July 2009
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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Existence of congenital anomalies and genetic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358891

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

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Suh-Fang Jeng, Sc.D    886-2-33228132    jeng@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Suh-Fang Jeng, Sc.D National Taiwan University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00358891     History of Changes
Other Study ID Numbers: 9461701282
Study First Received: July 30, 2006
Last Updated: August 1, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Prematurity
Chronic Lung Disease
Respiratory Health
Neurodevelopment
Preschool
Influencing Factors

Additional relevant MeSH terms:
Lung Diseases
Premature Birth
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 19, 2014