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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807533
• Other study ID #: 201103075RB
• Status: Completed
• Phase: N/A
• Start date: May 22, 2012
• Est. completion date: January 10, 2017

Study information

• Verified date: March 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: January 10, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Intervention

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
• 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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child: neurodevelopment functions (cognition, language and motor)	Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition	24 months of corrected age
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Transactional functions and change from baseline	Wakeful Position Questionnaire at 6 and 12 months of corrected age	6 and 12 months of corrected age
Secondary	Transactions function: affordance	1. Affordances in the Home Environment Motor Development- Chinese version	18 months of corrected age
Secondary	Child: Medical data	Chart review	Birth to 24 months of corrected age
Secondary	Child: growth data and change from baseline	Chart review and measurement	0, 1, 4, 6, 12, 18, and 24 months of corrected age
Secondary	Child: neurophysiological functions and change from baseline	Electroencephalogram/event-related potential	1 and 4 months of corrected age
Secondary	Child: genotyping and gene expression	Buccal cell collection	0 month of corrected age
Secondary	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