NCT00173108

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 cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 22, 2011

Status Verified

March 1, 2011

Enrollment Period

4.8 years

First QC Date

September 12, 2005

Last Update Submit

April 21, 2011

Conditions

Premature Birth

Keywords

PrematurityEarly interventionNeurodevelopmentCost-effectiveness

Outcome Measures

Primary Outcomes (1)

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

    Effectiveness includes the child (health, growth, neurodevelopment, and neurosensory), parent (competence, social support, and psychological stress) and transaction outcomes (parent-child interaction). Cost includes direct and indirect cost related to health and intervention program

    In-hospital, 6, 12, 18 and 24 months of age

Study Arms (4)

Term group

NO INTERVENTION

Usual care program group

NO INTERVENTION

Clinic-based interveniton program group

EXPERIMENTAL
Behavioral: clinic-based intervention program and home-based intervention program

Home-based interveniton program group

EXPERIMENTAL
Behavioral: clinic-based intervention program and home-based intervention program

Interventions

clinic-based intervention program and home-based intervention programBEHAVIORAL

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.

Clinic-based interveniton program groupHome-based interveniton program group

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Birth weight \>2,500 g;
  • Gestational age within 38-42 weeks,
  • Family living in the same geographic region as those of the VLBW preterm infants
  • Serious prenatal or perinatal complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

Related Publications (3)

  • Li SJ, Tsao PN, Tu YK, Hsieh WS, Yao NJ, Wu YT, Jeng SF. Cognitive and motor development in preterm children from 6 to 36 months of age: Trajectories, risk factors and predictability. Early Hum Dev. 2022 Sep;172:105634. doi: 10.1016/j.earlhumdev.2022.105634. Epub 2022 Jul 28.

    PMID: 35921693DERIVED

  • Su YH, Jeng SF, Hsieh WS, Tu YK, Wu YT, Chen LC. Gross Motor Trajectories During the First Year of Life for Preterm Infants With Very Low Birth Weight. Phys Ther. 2017 Mar 1;97(3):365-373. doi: 10.1093/ptj/pzx007.

    PMID: 28339607DERIVED

  • Wu YC, Leng CH, Hsieh WS, Hsu CH, Chen WJ, Gau SS, Chiu NC, Yang MC, Li-Jung Fang, Hsu HC, Yu YT, Wu YT, Chen LC, Jeng SF. A randomized controlled trial of clinic-based and home-based interventions in comparison with usual care for preterm infants: effects and mediators. Res Dev Disabil. 2014 Oct;35(10):2384-93. doi: 10.1016/j.ridd.2014.06.009. Epub 2014 Jun 26.

    PMID: 24973546DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Suh-Fang Jeng, Sc.D

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 22, 2011

Record last verified: 2011-03

Locations

TW(1)