Effects of Family-Centered Intervention for Preterm Infants at Preschool Age

NCT02533661 | Completed

• 1 other identifier: 201412127RINC
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Accumulating data on early intervention for preterm infants in Western countries have demonstrated short- to medium-term benefits on enhancing child cognitive outcome. Furthermore, the cumulative plasticity of dopamine-related genes may interact with environmental intervention in influencing a child's behavior. However, rare studies have examined the long-term effect of early intervention for preterm infants in Eastern society and whether the genetic markers interact with environmental intervention in shaping child developmental outcomes. To meet the contemporary concept of family-centered intervention and to adapt the findings of our previous studies into program design, we have developed a family-centered intervention program (FCIP) for preterm infants with very low birth weight (VLBW, birth weight \<1,500 g) in Taiwan and employed a multi-centered, randomized controlled study design to examine its short-term effects with respect to a usual care program (UCP) and its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and dyad-focused services that lasted from hospitalization until 12 months; the UCP contained child-focused services in hospitalization and phone calls after discharge. This three-year multi-centered study is therefore aimed to extend our research to examine the long-term effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. A total of 275 ( 269 participants + 6 pilots) VLBW preterm infants have been enrolled and randomly assigned to the FCIP and UCP, and their buccal cells samples have been collected for typing of dopamine-related genes. All infants and families will be examined at 3 and 4 years of age for child and parent outcomes. Child outcomes will include growth, health, cognition, language, motor function, and behavioral measures; parent outcomes will consist of parental stress and quality of life measures. The long-term effect of early intervention for preterm infants will provide important information to help medical/educational professionals and public policy makers develop and assess effective intervention for Taiwanese preterm children who are at risk of developmental disorders. Furthermore, the results will help reveal the gene and intervention interaction on child developmental outcome.

Conditions

Premature Birth

Keywords

Effectiveness; Genes; Intervention; Neurodevelopment; Prematurity; Preschool Age

Outcome Measures

Primary Outcomes (11)

• Child: Health status

  Chart review

  up to 2 years

• Child: Growth - weight

  weight will be assessed using an electric weight scale (kg)

  up to 2 years

• Child: Growth - height

  height will be assessed by the tape measure in standing position (cm)

  up to 2 years

• Child: Growth - head circumference

  head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)

  up to 2 years

• Child: Neurodevelopment - Bayley Scale of Infant and Toddler Development- 2nd and 3rd Edition

  The BSID-II is a norm-referenced developmental diagnostic test for infants aged from 1 month to 42 months. The assessment contains the Motor Scale (111 items), the Mental Scale (178 items), and the Behavioral Rating Scale (30 items).

  1 year

• Child: Neurodevelopment - The Wechsler Preschool and Primary Scale of Intelligence-Revised Edition

  The WPPSI-R measures cognitive development of children who aged from 3 to 7 years old. The test structure of WPPSIR-IV includes 12 subscales and three levels of interpretation: full intelligence quotient (FIQ); performance intelligence quotient (PIQ), and verbal intelligence quotient (VIQ).

  1 year

• Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition

  The Movement ABC-II examines the movement performance in children aged 3 years to 16 years and 11 months. The assessment contains eight items that measure a child's performance of age-appropriate tasks in the aspects of manual dexterity, aiming and catching, and balance.

  1 year

• Child: Behavior - Children's Behavior Questionnaire

  The CBQ is a parent-report temperament questionnaire for preschool- and school-aged children. A total of 195 items described children's reactions on 15 primary temperament characteristics: positive anticipation, smiling/laughter, high intensity pleasure, activity level, impulsivity, shyness, discomfort, fear, anger/frustration, sadness, soothability, inhibitory control, attentional focusing, low intensity pleasure, and perceptual sensitivity.

  1 year

• Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV

  The SNAP-IV questionnaire examines the severity of ADHD and ODD in preschool- and school-aged children. The scale employs the direct symptom of Diagnosis and Statistical Manual of Mental Disorder-IV (DSM-IV) that consists of inattention (nine items), hyperactivity/impulsivity (nine items) of the criteria for ADHD, and the oppositional symptoms (eight items) of the criteria for ODD.

  1 year

• Child: Behavior - Child Behavior Check List/1.5-5

  The CBCL/1.5-5 is a parent-report questionnaire designed to assess the behavior problems in children at 1.5 to 5 years of age. The CBCL/1.5-5 consists of 99 items to assess concerning behavioral/emotional problems.

  1 year

• Child: Neurodevelopment - The Berry-Buktenica Developmental Test of Visual-Motor Integration

  The VMI screens for visual-motor deficits in children from 2 to 18 years old and adults. The assessment contains visual-motor integration, visual perception and motor coordination.

  1 year

Secondary Outcomes (3)

• Parent: Parental stress - Parenting Stress Index/ Long Form

  1 year

• Parent: Quality of life - World Health Organization Quality of Life- Brief Taiwan Version

  1 year

• Child: Neurophysiological functions

  1 year

Study Arms (2)

Family-centered intervention program

EXPERIMENTAL

The FCIP group received: 1. In-hospital intervention: modulation of the NICU, teaching of child development skills, feeding support,massage,parent support and education,transition home preparation. 2. After-discharge: clinic (1, 2, 4, 9 months) and home visits (0, 6, 12 months) for teaching of child development skills, feeding support, dyadic interaction activities, modulations of home environment, parent support and education.

Other: Family-centered intervention program

Usual care program

NO INTERVENTION

The UCP group received: 1. In-hospital intervention: environmental modulation and teaching of child development skills. 2. After-discharge:telephone calls (0, 1, 2, 4, 6, 9 and 12 months): consultation on general care concerns

Interventions

Family-centered intervention program OTHER

This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education

Also known as: early intervention program

Family-centered intervention program

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• birth weight less than 1,500 gram
• gestational age lower than 37 weeks
• mothers older than 18 years of age;
• Taiwan nationality
• absence of maternal substance abuse (alcohol or drug)
• married or living together at delivery
• families residing in northern or southern Taiwan.

You may not qualify if:

• congenital abnormality
• severe neonatal and perinatal diseases: Severe neonatal diseases refer to major neurologic abnormalities (e.g., seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage and stage IV-V retinopathy of prematurity), necrotizing enterocolitis grade II and severe cardiopulmonary disease requiring daily oxygen use at hospital discharge that may require intensive developmental intervention and therefore did not suit for our interventions.
• Furthermore, infants exhibiting persistently unstable physiological conditions until 36 weeks' PMA or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases were early terminated.

Sponsors & Collaborators

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

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 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: 35921693 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Suh-Fang Jeng

  School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: November 11, 2018
• Study Completion: February 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2016-10

Locations

TW (1)