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Completed

NCT Number: NCT01807533

A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

Four hypotheses will be tested in this study:

1. The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period. 2. The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group. 3. Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants. 4. Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.

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Key information

Conditions

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

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital, Tainan, Taiwan

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About this study

A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • birth body weight < 1500 grams
  • gestational age < 37 weeks
  • parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi

Exclusion criteria

  • severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
  • congenital or chromosome abnormality
  • mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol, and drug)

Terminated Criteria:

  • diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
  • severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
  • hospital discharge beyond 44 weeks' post-menstrual age.

Treatment and study plan

Family-centered intervention program

Behavioral

This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The 7-session after-discharge intervention consisted 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

Other names: FCIP

Usual care intervention program

Behavioral

This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The after-discharge service was provided 7-phone calls for the general health consultation.

Other names: UCP

Primary outcomes

  1. Child: neurodevelopment functions (cognition, language and motor)

    Time frame: 24 months of corrected age

    Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition

Secondary outcomes

  1. Change of neurodevelopment functions (motor) from baseline

    Time frame: 0 months of corrected age

    The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version

  2. Child: neurodevelopment functions (behavior)

    Time frame: 24 months of corrected age

    Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version

  3. Change of neurodevelopment functions (cognition, language and motor) from baseline

    Time frame: 6,12, and 24 months

    Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version

  4. Parental functions and change from baseline (pressure)

    Time frame: 0, 6, 12, 18, and 24 months of corrected age

    Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version

  5. Parental functions and change from baseline (Quality of Life)

    Time frame: 0, 6, 12, 18, and 24 months of corrected age

    World Health Organization Quality of Life- Brief Taiwan version

  6. Transactional functions and change from baseline

    Time frame: 6, 12, and 18 months of corrected age

    Mother-infant interaction in free play at 6, 12, and 18 months of corrected age

  7. Transactional functions and change from baseline

    Time frame: 6 and 12 months of corrected age

    Wakeful Position Questionnaire at 6 and 12 months of corrected age

  8. Transactions function: affordance

    Time frame: 18 months of corrected age

    • Affordances in the Home Environment Motor Development- Chinese version

  9. Child: Medical data

    Time frame: Birth to 24 months of corrected age

    Chart review

  10. Child: growth data and change from baseline

    Time frame: 0, 1, 4, 6, 12, 18, and 24 months of corrected age

    Chart review and measurement

  11. Child: neurophysiological functions and change from baseline

    Time frame: 1 and 4 months of corrected age

    Electroencephalogram/event-related potential

  12. Child: genotyping and gene expression

    Time frame: 0 month of corrected age

    Buccal cell collection

  13. Parental adherence to Intervention

    Time frame: 32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months

    Only assessed in FCIP group

    • Parental motivation
    • Goal attainment
    • Home activity records

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Health Research Institutes, Taiwan

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2013
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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