AzTrials
AzTrials

Premature BirthNCT01807533

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

A study testing Family-centered intervention program in people with Premature Birth, run by National Taiwan University Hospital at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages Up to 36 weeks
Conditions the study is for
Premature Birth
What is being tested?
Family-centered intervention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
3 sitesTaiwan
Study dates
22 May 2012to 10 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 36 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 104

Other trials in Taiwan

About this study

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.
Read the 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.

Conditions
Premature Birth
Being tested
Family-centered intervention program, Usual care intervention program
Keywords
Environment, Gene, Intervention, Neurodevelopment, Pathways, Preterm infants
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family-centered intervention programBehavioural

    Also called FCIP

    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 programBehavioural

    Also called UCP

    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.

Study groups in NCT01807533
Study groupRoleWhat they receive
Family-centered intervention programExperimentalFCIP: 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.
Receives: Behavioral: Family-centered intervention program
Usual care intervention programOtherUCP: 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.
Receives: Behavioral: Usual care intervention program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 months of corrected age

Secondary outcomes (13)

  1. 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

    Measured: 0 months of corrected age

  2. Child: neurodevelopment functions (behavior)

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

    Measured: 24 months of corrected age

  3. 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

    Measured: 6,12, and 24 months

  4. Parental functions and change from baseline (pressure)

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

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

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

    World Health Organization Quality of Life- Brief Taiwan version

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

  6. Transactional functions and change from baseline

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

    Measured: 6, 12, and 18 months of corrected age

  7. Transactional functions and change from baseline

    Wakeful Position Questionnaire at 6 and 12 months of corrected age

    Measured: 6 and 12 months of corrected age

  8. Transactions function: affordance

    1. Affordances in the Home Environment Motor Development- Chinese version

    Measured: 18 months of corrected age

  9. Child: Medical data

    Chart review

    Measured: Birth to 24 months of corrected age

  10. Child: growth data and change from baseline

    Chart review and measurement

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

  11. Child: neurophysiological functions and change from baseline

    Electroencephalogram/event-related potential

    Measured: 1 and 4 months of corrected age

  12. Child: genotyping and gene expression

    Buccal cell collection

    Measured: 0 month of corrected age

  13. Parental adherence to Intervention

    Only assessed in FCIP group

    1. Parental motivation
    2. Goal attainment
    3. Home activity records

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2013 (estimated)
  2. Study start22 May 2012
  3. Primary completion10 Jan 2017
  4. Study completion10 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01807533
Sponsor's protocol ID
201103075RB
Status last verified
Mar 2017
First submitted
29 Jan 2013
Last updated
24 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35921693

  • 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.

    PubMed 31504897

Questions about this trial

What is this clinical trial studying?

A study testing Family-centered intervention program in people with Premature Birth, run by National Taiwan University Hospital at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child: neurodevelopment functions (cognition, language and motor) (time frame: 24 months of corrected age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01807533, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in