NCT01807533

Brief Summary

Four hypotheses will be tested in this study:

  1. 1.The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
  2. 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. 3.Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
Last Updated

August 24, 2018

Status Verified

March 1, 2017

Enrollment Period

4.6 years

First QC Date

January 29, 2013

Last Update Submit

August 22, 2018

Conditions

Premature Birth

Keywords

EnvironmentGeneInterventionNeurodevelopmentPathwaysPreterm infants

Outcome Measures

Primary Outcomes (1)

  • Child: neurodevelopment functions (cognition, language and motor)

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

    24 months of corrected age

Secondary Outcomes (13)

  • Change of neurodevelopment functions (motor) from baseline

    0 months of corrected age

  • Child: neurodevelopment functions (behavior)

    24 months of corrected age

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

    6,12, and 24 months

  • Parental functions and change from baseline (pressure)

    0, 6, 12, 18, and 24 months of corrected age

  • Parental functions and change from baseline (Quality of Life)

    0, 6, 12, 18, and 24 months of corrected age

  • +8 more secondary outcomes

Study Arms (2)

Family-centered intervention program

EXPERIMENTAL

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

Usual care intervention program

OTHER

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

Interventions

Family-centered intervention programBEHAVIORAL

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

Also known as: FCIP
Family-centered intervention program
Usual care intervention programBEHAVIORAL

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.

Also known as: UCP
Usual care intervention program

Eligibility Criteria

AgeUp to 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Related Publications (2)

  • 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: 35921693DERIVED

  • 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.

    PMID: 31504897DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Suh-Fang Jeng, Professor

    School and Graduate Institute of Physical Therapy, 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

January 29, 2013

First Posted

March 8, 2013

Study Start

May 22, 2012

Primary Completion

January 10, 2017

Study Completion

January 10, 2017

Last Updated

August 24, 2018

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)