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Effects of Early Intervention for Preterm Children at School Age

NCT01952093 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2018-08-09

No results posted yet for this study

Summary

Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight \< 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs developed for preterm infants in Western societies were shown to have short- to long-term benefits in certain cognitive functions, however, rare studies have investigated intervention effect at school age and explored plausible neurological pathway for effective intervention. This three-year study was therefore aimed to extend our previous research to longitudinally examine the effectiveness of three intervention programs (clinic-based intervention program \[CBIP\], home-based intervention program \[HBIP\] and usual care program \[UCP\]) for VLBW preterm children in Taiwan at seven years of age.(The intervention had been delivered from birth to one year of corrected age in the previous study. The intervention will not be given in this study.)The CBIP and HBIP contained similar child- and parent-focused services as well as interaction activities but were respectively delivered at the clinic for the CBIP and at home for the HBIP. A total of 178 VLBW preterm infants had been randomly assigned to the CBIP, HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal birth weight had also been included to serve as the reference group for comparison of developmental outcomes. Effectiveness examined included child and parent outcomes. The long-term effect of the early intervention for preterm children would provide important information to help medical professionals and public policy makers to develop an effective intervention for Taiwanese preterm children who are at risk of developmental disorders.

Conditions

  • Premature Birth

Interventions

BEHAVIORAL

Home-based intervention program

The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the home.

BEHAVIORAL

Clinic-based intervention program

The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the clinic.

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Suh-Fang Jeng, Sc.D · School of Physical Therapy, National Taiwan University

Eligibility

Min Age
7 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01952093 on ClinicalTrials.gov