Premature BirthNCT02533661
Effects of Family-Centered Intervention for Preterm Infants at Preschool Age
A study testing Family-centered intervention program in people with Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Accumulating data on early intervention for preterm infants in Western countries have demonstrated short- to medium-term benefits on enhancing child cognitive outcome. Furthermore, the cumulative plasticity of dopamine-related genes may interact with environmental intervention in influencing a child's behavior. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- 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
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to 1 Feb 2019
- 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 3 to 4 years
- All sexes
- No healthy volunteers
- Child
The inclusion criteria for VLBW preterm infants were:
- birth weight less than 1,500 gram
- gestational age lower than 37 weeks
The inclusion criteria for parents were:
- mothers older than 18 years of age;
- Taiwan nationality
- absence of maternal substance abuse (alcohol or drug)
- married or living together at delivery
- families residing in northern or southern Taiwan.
The exclusion criteria for VLBW preterm infants were:
- congenital abnormality
- severe neonatal and perinatal diseases: Severe neonatal diseases refer to major neurologic abnormalities (e.g., seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage and stage IV-V retinopathy of prematurity), necrotizing enterocolitis grade II and severe cardiopulmonary disease requiring daily oxygen use at hospital discharge that may require intensive developmental intervention and therefore did not suit for our interventions.
Furthermore, infants exhibiting persistently unstable physiological conditions until 36 weeks' PMA or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases were early terminated.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
About this study
Accumulating data on early intervention for preterm infants in Western countries have demonstrated short- to medium-term benefits on enhancing child cognitive outcome. Furthermore, the cumulative plasticity of dopamine-related genes may interact with environmental intervention in influencing a child's behavior. However, rare studies have examined the long-term effect of early intervention for preterm infants in Eastern society and whether the genetic markers interact with environmental intervention in shaping child developmental outcomes. To meet the contemporary concept of family-centered intervention and to adapt the findings of our previous studies into program design, we have developed a family-centered intervention program (FCIP) for preterm infants with very low birth weight (VLBW, birth weight <1,500 g) in Taiwan and employed a multi-centered, randomized controlled study design to examine its short-term effects with respect to a usual care program (UCP) and its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and dyad-focused services that lasted from hospitalization until 12 months; the UCP contained child-focused services in hospitalization and phone calls after discharge. This three-year multi-centered study is therefore aimed to extend our research to examine the long-term effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. A total of 275 ( 269 participants + 6 pilots) VLBW preterm infants have been enrolled and randomly assigned to the FCIP and UCP, and their buccal cells samples have been collected for typing of dopamine-related genes. All infants and families will be examined at 3 and 4 years of age for child and parent outcomes. Child outcomes will include growth, health, cognition, language, motor function, and behavioral measures; parent outcomes will consist of parental stress and quality of life measures. The long-term effect of early intervention for preterm infants will provide important information to help medical/educational professionals and public policy makers develop and assess effective intervention for Taiwanese preterm children who are at risk of developmental disorders. Furthermore, the results will help reveal the gene and intervention interaction on child developmental outcome.
Read the detailed description
Study Purposes:
This study is to extend our previous research to longitudinally examine the effectiveness of FCIP and UCP for VLBW preterm children in Taiwan at 3 and 4 years of age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. Effectiveness examined will include child and parent outcomes. Child outcomes will consist of growth, health, neurodevelopment (cognition, language and motor function) and behavior. Parent outcomes will include parental stress and quality of life. The long-term effect of early intervention for preterm children from the neonatal period to preschool age will provide important information to help medical professionals and public policy makers to develop effective intervention for Taiwanese preterm children who are at risk of developmental problems. Furthermore, the genetic susceptibility theory and the cumulative genetic plasticity theory will be used to examine the relations of polymorphisms of dopamine-related genes with child development and their possible interactions with environmental intervention on child development. Over twenty dopamine genetic markers that were identified in extensive research as being associated with plasticity for neurodevelopmental functions will be examined for their individual and synergistic influences on developmental outcomes.
Participants:
Two hundred and seventy-five VLBW preterm children participating in our previous study who were born or admitted at National Taiwan University Hospital (NTUH), Mackay Memorial Hospital (MMH) and National Cheng Kung University Hospital (NCKUH) during the period of April 2012 to December 2014 will be enrolled in this study.
Methods:
All families will be contacted via phone call and mail to participate in this study. Children and their parents will be examined for the following outcomes when the children approach 3 and 4 years of age. All measures will be conducted at the Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University, and the Cognitive Electrophysiology Laboratory, Institute of Cognitive Science, National Cheng Kung University. The outcome measures in this study will consist of the primary child outcome (growth, health, neurodevelopment [cognitive, language and motor function] and behavior) and the secondary parent outcome (parental stress and quality of life). Child neurodevelopment will be examined using the Bayley Scales of Infant Development- 2nd edition, Bayley Scales of Infant and Toddler Development-3rd edition, Movement Assessment Battery for Children-2nd Edition, and Wechsler PreSchool and Primary Scales of Intelligence-4th Edition. Child behavior will be examined using the Children's Behavior Questionnaire, Swanson, Nolan, and Pelham Questionnaire- 4th Edition, and Child Behavior Check List/4-18. Parental stress will be assessed using the Parenting Stress Index-Long Form and quality of life will be assessed using the Chinese Version World Health Organization Quality of Life- Brief Taiwan Version. Each assessment will be delineated as follows.
- Conditions
- Premature Birth
- Being tested
- Family-centered intervention program
- Keywords
- Effectiveness, Genes, Intervention, Neurodevelopment, Prematurity, Preschool Age
- 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 programOther
Also called early intervention program
This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist 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
| Study group | Role | What they receive |
|---|---|---|
| Family-centered intervention program | Experimental | The FCIP group received:
1. In-hospital intervention: modulation of the NICU, teaching of child development skills, feeding support,massage,parent support and education,transition home preparation.
2. After-discharge: clinic (1, 2, 4, 9 months) and home visits (0, 6, 12 months) for teaching of child development skills, feeding support, dyadic interaction activities, modulations of home environment, parent support and education. Receives: Other: Family-centered intervention program |
| Usual care program | No intervention | The UCP group received: 1. In-hospital intervention: environmental modulation and teaching of child development skills. 2. After-discharge:telephone calls (0, 1, 2, 4, 6, 9 and 12 months): consultation on general care concerns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child: Health status
Chart review
Measured: up to 2 years
Child: Growth - weight
weight will be assessed using an electric weight scale (kg)
Measured: up to 2 years
Child: Growth - height
height will be assessed by the tape measure in standing position (cm)
Measured: up to 2 years
Child: Growth - head circumference
head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)
Measured: up to 2 years
Child: Neurodevelopment - Bayley Scale of Infant and Toddler Development- 2nd and 3rd Edition
The BSID-II is a norm-referenced developmental diagnostic test for infants aged from 1 month to 42 months. The assessment contains the Motor Scale (111 items), the Mental Scale (178 items), and the Behavioral Rating Scale (30 items).
Measured: 1 year
Child: Neurodevelopment - The Wechsler Preschool and Primary Scale of Intelligence-Revised Edition
The WPPSI-R measures cognitive development of children who aged from 3 to 7 years old. The test structure of WPPSIR-IV includes 12 subscales and three levels of interpretation: full intelligence quotient (FIQ); performance intelligence quotient (PIQ), and verbal intelligence quotient (VIQ).
Measured: 1 year
Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
The Movement ABC-II examines the movement performance in children aged 3 years to 16 years and 11 months. The assessment contains eight items that measure a child's performance of age-appropriate tasks in the aspects of manual dexterity, aiming and catching, and balance.
Measured: 1 year
Child: Behavior - Children's Behavior Questionnaire
The CBQ is a parent-report temperament questionnaire for preschool- and school-aged children. A total of 195 items described children's reactions on 15 primary temperament characteristics: positive anticipation, smiling/laughter, high intensity pleasure, activity level, impulsivity, shyness, discomfort, fear, anger/frustration, sadness, soothability, inhibitory control, attentional focusing, low intensity pleasure, and perceptual sensitivity.
Measured: 1 year
Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
The SNAP-IV questionnaire examines the severity of ADHD and ODD in preschool- and school-aged children. The scale employs the direct symptom of Diagnosis and Statistical Manual of Mental Disorder-IV (DSM-IV) that consists of inattention (nine items), hyperactivity/impulsivity (nine items) of the criteria for ADHD, and the oppositional symptoms (eight items) of the criteria for ODD.
Measured: 1 year
Child: Behavior - Child Behavior Check List/1.5-5
The CBCL/1.5-5 is a parent-report questionnaire designed to assess the behavior problems in children at 1.5 to 5 years of age. The CBCL/1.5-5 consists of 99 items to assess concerning behavioral/emotional problems.
Measured: 1 year
Child: Neurodevelopment - The Berry-Buktenica Developmental Test of Visual-Motor Integration
The VMI screens for visual-motor deficits in children from 2 to 18 years old and adults. The assessment contains visual-motor integration, visual perception and motor coordination.
Measured: 1 year
Secondary outcomes (3)
Parent: Parental stress - Parenting Stress Index/ Long Form
The PSI-LF is a self-report questionnaire that measures parenting stress based on interrelationship between the child's and the parents'characteristics. The questionnaire has 101 items, rated on a 5-point Likert scale, and contains parental distress (PD), parent-child dysfunctional interaction (PCDI), and difficult child (DC) subscales.
Measured: 1 year
Parent: Quality of life - World Health Organization Quality of Life- Brief Taiwan Version
The WHOQOL-BREF-TW is a self-administered scale that examines the quality of life of an individual. Twenty eight items are grouped into general QOL and general health; 26 items are classified into physical, psychological, social relationship and environment domains. Items are scored from 1 to 5 on a Likert's scale.
Measured: 1 year
Child: Neurophysiological functions
Child's neurophysiological functions will be measured by the cognitive task (eg. Go-Nogo task and oddball task) with electroencephalogram (EEG)/event-related potential (ERP) technique for the participating children at 4 years old.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion11 Nov 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Suh-Fang Jeng, Principal investigator, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533661
- Sponsor's protocol ID
- 201412127RINC
- Status last verified
- Oct 2016
- First submitted
- 18 Aug 2015
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Family-Centered Intervention for Preterm Infants at Preschool Age
- ClinicalTrials.gov ID
- NCT02533661
- Acronym / sponsor ID
- 201412127RINC
- Conditions
- Premature Birth
- Keywords
- Effectiveness, Genes, Intervention, Neurodevelopment, Prematurity, Preschool Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2015
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accumulating data on early intervention for preterm infants in Western countries have demonstrated short- to medium-term benefits on enhancing child cognitive outcome. Furthermore, the cumulative plasticity of dopamine-related genes may interact with environmental intervention in influencing a child's behavior. However, rare studies have examined the long-term effect of early intervention for preterm infants in Eastern society and whether the genetic markers interact with environmental intervention in shaping child developmental outcomes. To meet the contemporary concept of family-centered intervention and to adapt the findings of our previous studies into program design, we have developed a family-centered intervention program (FCIP) for preterm infants with very low birth weight (VLBW, birth weight <1,500 g) in Taiwan and employed a multi-centered, randomized controlled study design to examine its short-term effects with respect to a usual care program (UCP) and its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and dyad-focused services that lasted from hospitalization until 12 months; the UCP contained child-focused services in hospitalization and phone calls after discharge. This three-year multi-centered study is therefore aimed to extend our research to examine the long-term effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. A total of 275 ( 269 participants + 6 pilots) VLBW preterm infants have been enrolled and randomly assigned to the FCIP and UCP, and their buccal cells samples have been collected for typing of dopamine-related genes. All infants and families will be examined at 3 and 4 years of age for child and parent outcomes. Child outcomes will include growth, health, cognition, language, motor function, and behavioral measures; parent outcomes will consist of parental stress and quality of life measures. The long-term effect of early intervention for preterm infants will provide important information to help medical/educational professionals and public policy makers develop and assess effective intervention for Taiwanese preterm children who are at risk of developmental disorders. Furthermore, the results will help reveal the gene and intervention interaction on child developmental outcome.
Detailed description
Study Purposes:
This study is to extend our previous research to longitudinally examine the effectiveness of FCIP and UCP for VLBW preterm children in Taiwan at 3 and 4 years of age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. Effectiveness examined will include child and parent outcomes. Child outcomes will consist of growth, health, neurodevelopment (cognition, language and motor function) and behavior. Parent outcomes will include parental stress and quality of life. The long-term effect of early intervention for preterm children from the neonatal period to preschool age will provide important information to help medical professionals and public policy makers to develop effective intervention for Taiwanese preterm children who are at risk of developmental problems. Furthermore, the genetic susceptibility theory and the cumulative genetic plasticity theory will be used to examine the relations of polymorphisms of dopamine-related genes with child development and their possible interactions with environmental intervention on child development. Over twenty dopamine genetic markers that were identified in extensive research as being associated with plasticity for neurodevelopmental functions will be examined for their individual and synergistic influences on developmental outcomes.
Participants:
Two hundred and seventy-five VLBW preterm children participating in our previous study who were born or admitted at National Taiwan University Hospital (NTUH), Mackay Memorial Hospital (MMH) and National Cheng Kung University Hospital (NCKUH) during the period of April 2012 to December 2014 will be enrolled in this study.
Methods:
All families will be contacted via phone call and mail to participate in this study. Children and their parents will be examined for the following outcomes when the children approach 3 and 4 years of age. All measures will be conducted at the Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University, and the Cognitive Electrophysiology Laboratory, Institute of Cognitive Science, National Cheng Kung University. The outcome measures in this study will consist of the primary child outcome (growth, health, neurodevelopment [cognitive, language and motor function] and behavior) and the secondary parent outcome (parental stress and quality of life). Child neurodevelopment will be examined using the Bayley Scales of Infant Development- 2nd edition, Bayley Scales of Infant and Toddler Development-3rd edition, Movement Assessment Battery for Children-2nd Edition, and Wechsler PreSchool and Primary Scales of Intelligence-4th Edition. Child behavior will be examined using the Children's Behavior Questionnaire, Swanson, Nolan, and Pelham Questionnaire- 4th Edition, and Child Behavior Check List/4-18. Parental stress will be assessed using the Parenting Stress Index-Long Form and quality of life will be assessed using the Chinese Version World Health Organization Quality of Life- Brief Taiwan Version. Each assessment will be delineated as follows.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-centered intervention program | Experimental | Other: Family-centered intervention programThe FCIP group received: 1. In-hospital intervention: modulation of the NICU, teaching of child development skills, feeding support,massage,parent support and education,transition home preparation. 2. After-discharge: clinic (1, 2, 4, 9 months) and home visits (0, 6, 12 months) for teaching of child development skills, feeding support, dyadic interaction activities, modulations of home environment, parent support and education. |
| Usual care program | No intervention | –The UCP group received: 1. In-hospital intervention: environmental modulation and teaching of child development skills. 2. After-discharge:telephone calls (0, 1, 2, 4, 6, 9 and 12 months): consultation on general care concerns |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-centered intervention programAlso: early intervention programThis program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist 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 | Family-centered intervention program |
Primary outcome
Child: Health status
Time frame: up to 2 years
Chart review
Child: Growth - weight
Time frame: up to 2 years
weight will be assessed using an electric weight scale (kg)
Child: Growth - height
Time frame: up to 2 years
height will be assessed by the tape measure in standing position (cm)
Child: Growth - head circumference
Time frame: up to 2 years
head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)
Child: Neurodevelopment - Bayley Scale of Infant and Toddler Development- 2nd and 3rd Edition
Time frame: 1 year
The BSID-II is a norm-referenced developmental diagnostic test for infants aged from 1 month to 42 months. The assessment contains the Motor Scale (111 items), the Mental Scale (178 items), and the Behavioral Rating Scale (30 items).
Child: Neurodevelopment - The Wechsler Preschool and Primary Scale of Intelligence-Revised Edition
Time frame: 1 year
The WPPSI-R measures cognitive development of children who aged from 3 to 7 years old. The test structure of WPPSIR-IV includes 12 subscales and three levels of interpretation: full intelligence quotient (FIQ); performance intelligence quotient (PIQ), and verbal intelligence quotient (VIQ).
Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
Time frame: 1 year
The Movement ABC-II examines the movement performance in children aged 3 years to 16 years and 11 months. The assessment contains eight items that measure a child's performance of age-appropriate tasks in the aspects of manual dexterity, aiming and catching, and balance.
Child: Behavior - Children's Behavior Questionnaire
Time frame: 1 year
The CBQ is a parent-report temperament questionnaire for preschool- and school-aged children. A total of 195 items described children's reactions on 15 primary temperament characteristics: positive anticipation, smiling/laughter, high intensity pleasure, activity level, impulsivity, shyness, discomfort, fear, anger/frustration, sadness, soothability, inhibitory control, attentional focusing, low intensity pleasure, and perceptual sensitivity.
Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
Time frame: 1 year
The SNAP-IV questionnaire examines the severity of ADHD and ODD in preschool- and school-aged children. The scale employs the direct symptom of Diagnosis and Statistical Manual of Mental Disorder-IV (DSM-IV) that consists of inattention (nine items), hyperactivity/impulsivity (nine items) of the criteria for ADHD, and the oppositional symptoms (eight items) of the criteria for ODD.
Child: Behavior - Child Behavior Check List/1.5-5
Time frame: 1 year
The CBCL/1.5-5 is a parent-report questionnaire designed to assess the behavior problems in children at 1.5 to 5 years of age. The CBCL/1.5-5 consists of 99 items to assess concerning behavioral/emotional problems.
Child: Neurodevelopment - The Berry-Buktenica Developmental Test of Visual-Motor Integration
Time frame: 1 year
The VMI screens for visual-motor deficits in children from 2 to 18 years old and adults. The assessment contains visual-motor integration, visual perception and motor coordination.
3 secondary outcomes
Parent: Parental stress - Parenting Stress Index/ Long Form
Time frame: 1 year
Parent: Quality of life - World Health Organization Quality of Life- Brief Taiwan Version
Time frame: 1 year
Child: Neurophysiological functions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 35921693Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suh-Fang Jeng principal investigator
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
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 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Health status (time frame: up to 2 years). The study lists 11 primary outcomes in all. 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 NCT02533661, which also lists 1 linked publication.
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 7 Mar 2019.