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Early Intervention for Preterm Infants
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, August 2006
Sponsors and Collaborators: National Taiwan University Hospital
National Health Research Institutes, Taiwan
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00173108
  Purpose

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.


Condition Intervention
Premature Birth
Behavioral: child development

MedlinePlus related topics: Parenting
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan.

Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
Detailed Description:

Preterm birth with very low birth weight (VLBW) (gestational age <37 weeks and birth weight <1,501 g) is a significant public health problem worldwide. Longitudinal follow-up studies showed that VLBW preterm infants require prolonged hospitalization and are at substantial risk for various morbidities during neonatal period than those born at normal birth weight. Furthermore, approximately 40% of VLBW preterm infants are burden with adverse outcomes from chronic health problems and re-hospitalizations, to lower IQ, developmental delays, behavioral problems, and poor educational achievement. Accumulating data collected in Western developed countries have suggested that comprehensive and intensive early interventions may be beneficial for preterm infants and their families. However, there is little information concerning what early intervention should be attempted for these infants and their families in Taiwan. The purpose of this study is therefore to examine the cost-effectiveness of three early intervention programs i.e., the usual care program, the clinic-based intervention program, and the home-based intervention program for VLBW preterm infants. In a preliminary study, we surveyed the need of intervention services following hospital discharge in VLBW preterm infants (N=69) and their families. All mothers expressed the need of services that 60 (87%) preferred service delivery at home and 9 (13%) preferred service delivery at neonatal follow-up clinic. The intervention services specifically identified were health and respiratory assistance (N=22), feeding assistance (N=17), education of child development skills (N=12), and parent support (N=8). Based on these survey data and the results of previous intervention studies, we will develop in this proposed research project a clinic-based intervention program and a home-based intervention program that have common intervention services but are respectively delivered via clinic visit and home visit. 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.

This will be a four-year research project that employs a single blind, randomized experimental design to examine the efficacy of the early intervention programs for VLBW preterm infants. For the first year, we will develop the clinic-based intervention program and the home-based intervention programs in the actual situations to examine their clinical usefulness. From the second to the fourth year, 150 VLBW preterm infants who are born and admitted to the neonatal intensive care units of National Taiwan University Hospital and MacKay Memorial Hospital will be randomly assigned to the usual care program, the clinic-based intervention program, and the home-based intervention program. Fifty gender and socio-economically matched normal full-term infants will also be included as a comparison group. Child, parenting, and transactions outcomes will be assessed when infants are at 4, 6, 12, 18, and 24 months of corrected age. Child outcomes are measured by health status, growth, neurodevelopment, and neurosensory status; parenting outcomes are measured by maternal parenting competence, social support, and psychological stress; transactions outcome is measured by mother-infant interaction. Generalized estimating equations will be used to examine the differences in changes of outcome variables between intervention and control groups. At the end of the fourth year, the costs and effectiveness of the three intervention programs will be compared to determine which one is more cost-effective for VLBW preterm infants in Taiwan. The results of this study will help clinicians and parents understand the efficacy of early intervention for VLBW preterm infants. Furthermore, the data of this study will provide important information to policy makers and health administrators concerning resource allocation of early intervention forVLBW preterm infants in Taiwan.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BW below 1,501 gm
  • GA under 37 weeks
  • Admission to the NICU within the first 7 days of life
  • Physiologically stable at PCA 36 weeks as diagnosed by attending physician
  • Hospital discharge prior to PCA 40 weeks
  • Absence of congenital anomalies and/or severe neonatal diseases
  • Family residence in the greater Taipei area.

Exclusion Criteria:

  • Severe neonatal diseases included major neurologic abnormalities (such as seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, and grade IV retinopathy of prematurity)
  • Necrotizing enterocolitis with colostomy
  • Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00173108

Contacts
Contact: Suh-Fang Jeng, Sc.D 886-2-23123456 ext 7557 jeng@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Suh-Fang Jeng, Sc.D     886-2-23123456 ext 7557     jeng@ntu.edu.tw    
Principal Investigator: Suh-Fang Jeng, Sc.D            
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Suh-Fang Jeng, Sc.D National Taiwan University
  More Information

Study ID Numbers: 9461700406
Study First Received: September 12, 2005
Last Updated: September 7, 2006
ClinicalTrials.gov Identifier: NCT00173108  
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Prematurity
Early intervention
Neurodevelopment
Cost-effectiveness

Study placed in the following topic categories:
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 16, 2009