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Early Intervention for Preterm Infants

NCT00173108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-04-22

No results posted yet for this study

Summary

The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.

The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.

Conditions

  • Premature Birth

Interventions

BEHAVIORAL

clinic-based intervention program and home-based intervention program

The intervention includes education of child development skills, health and feeding consultation, intervention of mother-infant interaction, and parent support. Clinic-based intervention program is delivered in clinic while home-based intervention program is delivered at home.

Sponsors & Collaborators

  • National Taiwan University

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Suh-Fang Jeng, Sc.D · National Taiwan University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Taiwan

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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 NCT00173108 on ClinicalTrials.gov