A Longitudinal Study of Effectiveness of Early Intervention for Preterm Infants

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00946244
First received: July 22, 2009
Last updated: November 16, 2009
Last verified: November 2009
  Purpose

The main purpose of this study is to extend the investigators' previous research to longitudinally examine the effectiveness of three early intervention programs: usual care program, clinic-based intervention program and home-based intervention program for very low birth weight preterm children at 3 and 4 years of age. Normal weight full-term children will also be included to serve as the reference group. Effectiveness assessments will include child, parenting, and transactions measures. Child outcome measures will include health status, growth, neurodevelopment and behavior; parenting outcome measures will include parental stress, competence, efficacy and family support; transactions outcome measure will include parent-child interaction procedures.


Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Effectiveness of Early Intervention for Preterm Infants

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Child's development (health, growth, neurodevelopment and behavior) [ Time Frame: 3 and 4 years of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Parenting function (parent stress, competency, efficacy and family support) [ Time Frame: 3 and 4 years of age ] [ Designated as safety issue: Yes ]
  • Parent-child transactions [ Time Frame: 3 and 4 years of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: August 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Term infants
Healthy term infants
Usual care program
VLBW preterm infants who received usual medical care during hospitalization after birth
Clinic-based intervention program
VLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in previous study)
Home-based intervention program
VLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in previous study)

Detailed Description:

Accumulating data on early intervention for preterm infants illustrated short-term benefits on enhancing child development and decreasing parental stress, particularly for those of heavier birth weights. However, rare studies had designed early intervention program for small preterm infants and longitudinally examined the effectiveness in various outcome domains. Our research team recently conducted a clinical randomization trial on the effectiveness of three early intervention programs: usual care program (UCP), clinic-based intervention program (CBIP) and home-based intervention program (HBIP) on very low birth weight (VLBW, birth weight <1,500 g) preterm infants from the neonatal period to two years corrected age (CA). The latter two were comprehensive, intensive intervention programs that combined child- and parent-focused services beginning in hospitalization and ending at one year CA as delivered at clinic and home respectively. This three-year research project has extended our previous work to longitudinally examine the effectiveness of the three intervention programs in 180 VLBW preterm infants at 3 and 4 years of age. Sixty full-term infants will also be included to serve as the reference group. Outcome measures will include child (i.e., health, growth, neurodevelopment and behavior), parenting (i.e., parental stress, competency, efficacy and family support) and mother-child transactions (i.e., free-play and frustrating episode). The longitudinal data on the effectiveness of these early intervention programs for VLBW preterm infants will provide important information to help early intervention professionals and public policy makers to develop effective intervention for preterm children at risk for developmental problems.

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Term and VLBW preterm children were born at the National Taiwan University Hospital and the Mackay Memorial Hospital (MMH)

Criteria

Inclusion Criteria:

  • Body weight below 1501 gm
  • Gestational age under 37 weeks
  • Admission to the study hospitals within the first 7 days of life
  • Singleton or the first child of twin or multiple births
  • Physiologically stable at PCA 36 weeks as determined by attending physician
  • Hospital discharge prior to PCA 44 weeks

Exclusion Criteria:

  • Seizure
  • Hydrocephalus
  • Ventriculoperitoneal shunt
  • Meningitis, periventricular leukomalacia
  • Grade III to IV intraventricular hemorrhage
  • Stage 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: NCT00946244

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Suh-Fang Jeng, Sc.D National Taiwan University
  More Information

No publications provided

Responsible Party: Suh-Fang, Jeng, National Taiwan University
ClinicalTrials.gov Identifier: NCT00946244     History of Changes
Other Study ID Numbers: 200812114R
Study First Received: July 22, 2009
Last Updated: November 16, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Early intervention
Mother-child interaction
Neurodevelopment
Parenting
Prematurity
Preschool age

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 22, 2014