Effects of Early Intervention for Preterm Children at School Age

NCT01952093 | Completed

• 1 other identifier: 201112106RIB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight \< 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs developed for preterm infants in Western societies were shown to have short- to long-term benefits in certain cognitive functions, however, rare studies have investigated intervention effect at school age and explored plausible neurological pathway for effective intervention. This three-year study was therefore aimed to extend our previous research to longitudinally examine the effectiveness of three intervention programs (clinic-based intervention program \[CBIP\], home-based intervention program \[HBIP\] and usual care program \[UCP\]) for VLBW preterm children in Taiwan at seven years of age.(The intervention had been delivered from birth to one year of corrected age in the previous study. The intervention will not be given in this study.)The CBIP and HBIP contained similar child- and parent-focused services as well as interaction activities but were respectively delivered at the clinic for the CBIP and at home for the HBIP. A total of 178 VLBW preterm infants had been randomly assigned to the CBIP, HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal birth weight had also been included to serve as the reference group for comparison of developmental outcomes. Effectiveness examined included child and parent outcomes. The long-term effect of the early intervention for preterm children would provide important information to help medical professionals and public policy makers to develop an effective intervention for Taiwanese preterm children who are at risk of developmental disorders.

Conditions

Premature Birth

Keywords

Early intervention; Mother-child interaction; Neurodevelopment; Parenting; Prematurity; School age

Outcome Measures

Primary Outcomes (1)

• Child neurobehavioral development

  Child neurobehavioral assessment including cognitive and, motor, and behavior functions. Cognitive functions were assessed by the intelligence (IQ test), the efficiency of attention control (sustained attention test), and the cognitive flexibility and planning (executive function test). Motor functions assessment included motor skill acquisition and coordination. Child's behavior was measured by the parent/teacher reported questionnaire (two different versions) of child's adaptive behavior in the school context.

  at 7 years of age

Secondary Outcomes (6)

• Parenting

  at 7 years of age

• Child health condition

  at 7 years of age

• Child neurophysiological functions

  at 7 years of age

• Child educational resources

  at 7 years of age

• Child growth-weight

  at 7 years of age

Study Arms (4)

Usual care program

VLBW preterm infants who received usual medical care during hospitalization after birth.(in the previous study)

Clinic-based intervention program

VLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in the previous study)

Behavioral: Clinic-based intervention program

Home-based intervention program

VLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in the previous study)

Behavioral: Home-based intervention program

Term control group

Healthy term infants

Interventions

Home-based intervention program BEHAVIORAL

The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the home.

Also known as: HBIP

Home-based intervention program

Clinic-based intervention program BEHAVIORAL

The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the clinic.

Also known as: CBIP

Clinic-based intervention program

Eligibility Criteria

• Age: 7 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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) and who received the intervention service in our previous intervention study will be invited to participate in this study.

You may not qualify if:

• Infants exhibiting persistently unstable physiological conditions until 36 weeks' post- menstrual age (PMA) or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases (e.g., seizure, hydrocephalus, ventriculoperitoneal shunt, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, necrotizing enterocolitis with colostomy, and stage IV-V retinopathy of prematurity) were early terminated in this study.
• Additional selection criteria for all infants in this study were as follows: mothers who read and speak Chinese, maternal age older than 18 years, absence of maternal alcohol or drug abuse history, and parents married at child's birth.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Suh-Fang Jeng, Sc.D

  School of Physical Therapy, 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: September 18, 2013
• First Posted: September 27, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 9, 2018

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)