Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173108
Status:
COMPLETED
Last Update Posted:
2011-04-22
First Post:
2005-09-12
Brief Title:
Early Intervention for Preterm Infants
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Early Intervention for Preterm Infants
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 costeffectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants
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 costeffectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants
Detailed Description:
Preterm birth with very low birth weight VLBW gestational age 37 weeks and birth weight 1501 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 ie 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 N69 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 N22 feeding assistance N17 education of child development skills N12 and parent support N8 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 180 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 Sixty 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
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 180 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 Sixty 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None