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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Family-centered intervention program; Behavioral: Usual care intervention program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family-centered intervention program; FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.	Behavioral: Family-centered intervention program; 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
Other: Usual care intervention program; UCP: family members were invited to present at least one session of the 5 in-hospital intervention session. Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.	Behavioral: Usual care intervention program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child: neurodevelopment functions (cognition, language and motor)	Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition	24 months of corrected age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of neurodevelopment functions (motor) from baseline	The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version	0 months of corrected age
Child: neurodevelopment functions (behavior)	Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version	24 months of corrected age
Change of neurodevelopment functions (cognition, language and motor) from baseline	Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version	6,12, and 24 months
Parental functions and change from baseline (pressure)	Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version	0, 6, 12, 18, and 24 months of corrected age
Parental functions and change from baseline (Quality of Life)	World Health Organization Quality of Life- Brief Taiwan version	0, 6, 12, 18, and 24 months of corrected age
Transactional functions and change from baseline	Mother-infant interaction in free play at 6, 12, and 18 months of corrected age	6, 12, and 18 months of corrected age
Transactional functions and change from baseline	Wakeful Position Questionnaire at 6 and 12 months of corrected age	6 and 12 months of corrected age
Transactions function: affordance	1. Affordances in the Home Environment Motor Development- Chinese version	18 months of corrected age
Child: Medical data	Chart review	Birth to 24 months of corrected age
Child: growth data and change from baseline	Chart review and measurement	0, 1, 4, 6, 12, 18, and 24 months of corrected age
Child: neurophysiological functions and change from baseline	Electroencephalogram/event-related potential	1 and 4 months of corrected age
Child: genotyping and gene expression	Buccal cell collection	0 month of corrected age
Parental adherence to Intervention	Only assessed in FCIP group; Parental motivation; Goal attainment; Home activity records	32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Health Research Institutes, Taiwan

Publications and helpful links

General Publications

• 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.
• Yu YT, Huang WC, Hsieh WS, Chang JH, Lin CH, Hsieh S, Lu L, Yao NJ, Fan PC, Lee CL, Tu YK, Jeng SF. Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial. Phys Ther. 2019 Dec 16;99(12):1690-1702. doi: 10.1093/ptj/pzz120.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2012
• Primary Completion (Actual): January 10, 2017
• Study Completion (Actual): January 10, 2017

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Intervention; Environment; Neurodevelopment; Preterm infants; Gene; Pathways
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 201103075RB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No