NCT00946244

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

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

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 23, 2017

Status Verified

November 1, 2009

Enrollment Period

3 years

First QC Date

July 22, 2009

Last Update Submit

February 21, 2017

Conditions

Premature Birth

Keywords

Early interventionMother-child interactionNeurodevelopmentParentingPrematurityPreschool age

Outcome Measures

Primary Outcomes (1)

  • Child's development (health, growth, neurodevelopment and behavior)

    3 and 4 years of age

Secondary Outcomes (2)

  • Parenting function (parent stress, competency, efficacy and family support)

    3 and 4 years of age

  • Parent-child transactions

    3 and 4 years of age

Study Arms (4)

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)

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 23, 2017

Record last verified: 2009-11

Locations

TW(1)