Premature BirthNCT01952093
Effects of Early Intervention for Preterm Children at School Age
An observational study of Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning… Read more about this study
- Who is it for?
- Ages 7 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Home-based intervention program and Clinic-based intervention program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to Sep 2015
- Phase
- Observational
- 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 7 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term and VLBW preterm children were born at the National Taiwan University Hospital and the Mackay Memorial Hospital (MMH) and who received the intervention service in our previous intervention study will be invited to participate in this study.
Seven years old children who received the intervention service in our previous intervention study will be invited to participate in this study.
- The inclusion criteria for term infants were: birth weight greater than 2500 g, gestational age within 38-42 weeks, and the absence of serious prenatal and perinatal complications.
- The inclusion criteria for VLBW preterm infants were: birth weight less than 1500 g, gestational age less than 37 weeks, and the singleton or the first child of twin/multiple birth.
- The exclusion criteria for VLBW preterm infants were: admission to the study hospitals >7 days of birth and infants with congenital anomalies or severe neonatal diseases.
- Infants exhibiting persistently unstable physiological conditions until 36 weeks' post- menstrual age (PMA) or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases (e.g., seizure, hydrocephalus, ventriculoperitoneal shunt, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, necrotizing enterocolitis with colostomy, and stage IV-V retinopathy of prematurity) were early terminated in this study.
- Additional selection criteria for all infants in this study were as follows: mothers who read and speak Chinese, maternal age older than 18 years, absence of maternal alcohol or drug abuse history, and parents married at child's birth.
Trial locations and contacts
1 site in 1 country.
About this study
Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs developed for preterm infants in Western societies were shown to have short- to long-term benefits in certain cognitive functions, however, rare studies have investigated intervention effect at school age and explored plausible neurological pathway for effective intervention. This three-year study was therefore aimed to extend our previous research to longitudinally examine the effectiveness of three intervention programs (clinic-based intervention program [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW preterm children in Taiwan at seven years of age.(The intervention had been delivered from birth to one year of corrected age in the previous study. The intervention will not be given in this study.)The CBIP and HBIP contained similar child- and parent-focused services as well as interaction activities but were respectively delivered at the clinic for the CBIP and at home for the HBIP. A total of 178 VLBW preterm infants had been randomly assigned to the CBIP, HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal birth weight had also been included to serve as the reference group for comparison of developmental outcomes. Effectiveness examined included child and parent outcomes. The long-term effect of the early intervention for preterm children would provide important information to help medical professionals and public policy makers to develop an effective intervention for Taiwanese preterm children who are at risk of developmental disorders.
Read the detailed description
Specific Aims:
This study was to extend our previous research to longitudinally examine the effectiveness of three intervention programs (CBIP, HBIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children were also included to serve as the reference group for comparison of developmental outcomes. The intervention had been delivered from birth to one year of corrected age in the previous study. Effectiveness examined including children's and parental outcomes. Primary outcome referred to measures of child neurobehavioral functions. Neurobehavioral assessment included cognitive, motor and behavioral measurement. Secondary outcomes referred to child growth and health, neurophysiological functions, and the quality of parenting measures. Neurophysiological assessment referred to electroencephalogram/event-related potential examinations that were used to investigate the neurological pathways underlying the effective intervention.
Subjects and Methods:
Participants:
One hundred and seventy-eight VLBW preterm children and 62 term children who had participated in our previous study were enrolled in this study. VLBW preterm children were born or admitted at the National Taiwan University Hospital, the Mackay Memorial Hospital and Taipei City Hospital, Branch for Women and Children in Taipei, Taiwan, during the time period of 2006 to 2008.
Methods:
While age seven is an important time period that children enter elementary school and begin to participate in school activities, more comprehensive outcome measurements are required. The World Health Organization emphasizes that health conditions should be considered from the body, individuals and societal perspectives as depicted in the International Classification of Functioning, Disability and Health model. Accordingly, the outcome measures in this study consisted of the primary (i.e., child neurobehavioral functions) and secondary outcomes (i.e., child growth and health, neurophysiological functions, and quality of parenting). Child neurobehavioral assessment included measurements of cognitive, motor, and behavior function. The domains of cognitive functions examined including the intelligence (IQ test), the efficiency of attention control (sustained attention test), and the cognitive flexibility and planning (executive function test). The motor function included motor skill acquisition and coordination. Children's behavior was measured using the parental report of child behavior and teacher's observation for child's adaptive behavior in the school context. Children's educational resources (special education or resource class) or other education-related support received from any institution would also be recorded in this study. Child neurophysiological functions were measured by the electroencephalogram (EEG)/event-related potential (ERP) technique.
All families were contacted via phone call and mail to be enrolled in this study. Children and their parents would have been examined for the following outcomes when the children approached at seven years of age. All measures except for the neurophysiological measures were conducted at Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University. Several examiners with the background knowledge of physical therapy or psychology received training with the testing instruments and procedures. Before commencing the study assessments, the interrater reliability (agreement with an experienced investigator > 0.80) would have been required for the assessors. All the examiners were kept blind to children's group assignment. To decrease the fatigue in children due to the prolonged examination, participants were asked to return twice for assessment.The first assessment would have taken 180 minutes which consisted of the IQ test, sustained attention test, and executive function test that the whole session.The second assessment was the neurophysiological measurement with the EEG/ERP tasks which would have taken 90 minutes.
- Conditions
- Premature Birth
- Being tested
- Home-based intervention program, Clinic-based intervention program
- Keywords
- Early intervention, Mother-child interaction, Neurodevelopment, Parenting, Prematurity, School 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.
Home-based intervention programBehavioural
Also called HBIP
The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the home.
Clinic-based intervention programBehavioural
Also called CBIP
The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Usual care program | VLBW preterm infants who received usual medical care during hospitalization after birth.(in the previous study) | |
| Clinic-based intervention program | VLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in the previous study) Receives: Behavioral: Clinic-based intervention program | |
| Home-based intervention program | VLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in the previous study) Receives: Behavioral: Home-based intervention program | |
| Term control group | Healthy term infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child neurobehavioral development
Child neurobehavioral assessment including cognitive and, motor, and behavior functions.
Cognitive functions were assessed by the intelligence (IQ test), the efficiency of attention control (sustained attention test), and the cognitive flexibility and planning (executive function test).
Motor functions assessment included motor skill acquisition and coordination. Child's behavior was measured by the parent/teacher reported questionnaire (two different versions) of child's adaptive behavior in the school context.
Measured: at 7 years of age
Secondary outcomes (6)
Parenting
The parental outcome was measured with the quality of parenting.
Measured: at 7 years of age
Child health condition
Child health condition were measured by a parent report questionnaire and chart review.
Measured: at 7 years of age
Child neurophysiological functions
Child's neurophysiological functions were measured by the electroencephalogram (EEG)/event-related potential (ERP) technique for the participating children.
Measured: at 7 years of age
Child educational resources
The utility of special education and resource classes and the receiving of other educational support from any institution were also be recorded in this study.
Measured: at 7 years of age
Child growth-weight
Child's weight was measured by electronic weighting scale in kilogram
Measured: at 7 years of age
Child growth-height
Child's weight was measured by Kidmeasure in centimeter
Measured: at 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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, Sc.D, Principal investigator, School of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952093
- Sponsor's protocol ID
- 201112106RIB
- Status last verified
- Apr 2016
- First submitted
- 18 Sep 2013
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Intervention for Preterm Children at School Age
- ClinicalTrials.gov ID
- NCT01952093
- Acronym / sponsor ID
- 201112106RIB
- Conditions
- Premature Birth
- Keywords
- Early intervention, Mother-child interaction, Neurodevelopment, Parenting, Prematurity, School age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- May 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Sep 2013 (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.
Despite the remarkable achievements in neonatal survival of preterm infants with very low birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have produced little change in their prevalence of severe developmental disability and the rate of low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs developed for preterm infants in Western societies were shown to have short- to long-term benefits in certain cognitive functions, however, rare studies have investigated intervention effect at school age and explored plausible neurological pathway for effective intervention. This three-year study was therefore aimed to extend our previous research to longitudinally examine the effectiveness of three intervention programs (clinic-based intervention program [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW preterm children in Taiwan at seven years of age.(The intervention had been delivered from birth to one year of corrected age in the previous study. The intervention will not be given in this study.)The CBIP and HBIP contained similar child- and parent-focused services as well as interaction activities but were respectively delivered at the clinic for the CBIP and at home for the HBIP. A total of 178 VLBW preterm infants had been randomly assigned to the CBIP, HBIP or UCP. Sixty-two gender and maternal education level matched term children with normal birth weight had also been included to serve as the reference group for comparison of developmental outcomes. Effectiveness examined included child and parent outcomes. The long-term effect of the early intervention for preterm children would provide important information to help medical professionals and public policy makers to develop an effective intervention for Taiwanese preterm children who are at risk of developmental disorders.
Detailed description
Specific Aims:
This study was to extend our previous research to longitudinally examine the effectiveness of three intervention programs (CBIP, HBIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children were also included to serve as the reference group for comparison of developmental outcomes. The intervention had been delivered from birth to one year of corrected age in the previous study. Effectiveness examined including children's and parental outcomes. Primary outcome referred to measures of child neurobehavioral functions. Neurobehavioral assessment included cognitive, motor and behavioral measurement. Secondary outcomes referred to child growth and health, neurophysiological functions, and the quality of parenting measures. Neurophysiological assessment referred to electroencephalogram/event-related potential examinations that were used to investigate the neurological pathways underlying the effective intervention.
Subjects and Methods:
Participants:
One hundred and seventy-eight VLBW preterm children and 62 term children who had participated in our previous study were enrolled in this study. VLBW preterm children were born or admitted at the National Taiwan University Hospital, the Mackay Memorial Hospital and Taipei City Hospital, Branch for Women and Children in Taipei, Taiwan, during the time period of 2006 to 2008.
Methods:
While age seven is an important time period that children enter elementary school and begin to participate in school activities, more comprehensive outcome measurements are required. The World Health Organization emphasizes that health conditions should be considered from the body, individuals and societal perspectives as depicted in the International Classification of Functioning, Disability and Health model. Accordingly, the outcome measures in this study consisted of the primary (i.e., child neurobehavioral functions) and secondary outcomes (i.e., child growth and health, neurophysiological functions, and quality of parenting). Child neurobehavioral assessment included measurements of cognitive, motor, and behavior function. The domains of cognitive functions examined including the intelligence (IQ test), the efficiency of attention control (sustained attention test), and the cognitive flexibility and planning (executive function test). The motor function included motor skill acquisition and coordination. Children's behavior was measured using the parental report of child behavior and teacher's observation for child's adaptive behavior in the school context. Children's educational resources (special education or resource class) or other education-related support received from any institution would also be recorded in this study. Child neurophysiological functions were measured by the electroencephalogram (EEG)/event-related potential (ERP) technique.
All families were contacted via phone call and mail to be enrolled in this study. Children and their parents would have been examined for the following outcomes when the children approached at seven years of age. All measures except for the neurophysiological measures were conducted at Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University. Several examiners with the background knowledge of physical therapy or psychology received training with the testing instruments and procedures. Before commencing the study assessments, the interrater reliability (agreement with an experienced investigator > 0.80) would have been required for the assessors. All the examiners were kept blind to children's group assignment. To decrease the fatigue in children due to the prolonged examination, participants were asked to return twice for assessment.The first assessment would have taken 180 minutes which consisted of the IQ test, sustained attention test, and executive function test that the whole session.The second assessment was the neurophysiological measurement with the EEG/ERP tasks which would have taken 90 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care program | – | –VLBW preterm infants who received usual medical care during hospitalization after birth.(in the previous study) |
| Clinic-based intervention program | – | Behavioral: Clinic-based intervention programVLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in the previous study) |
| Home-based intervention program | – | Behavioral: Home-based intervention programVLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in the previous study) |
| Term control group | – | –Healthy term infants |
Who may qualify
- Ages
- 7 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term and VLBW preterm children were born at the National Taiwan University Hospital and the Mackay Memorial Hospital (MMH) and who received the intervention service in our previous intervention study will be invited to participate in this study.
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 |
|---|---|---|
| Home-based intervention programAlso: HBIPThe intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the home. | Behavioural | Home-based intervention program |
| Clinic-based intervention programAlso: CBIPThe intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the clinic. | Behavioural | Clinic-based intervention program |
Primary outcome
Child neurobehavioral development
Time frame: at 7 years of age
Child neurobehavioral assessment including cognitive and, motor, and behavior functions. Cognitive functions were assessed by the intelligence (IQ test), the efficiency of attention control (sustained attention test), and the cognitive flexibility and planning (executive function test). Motor functions assessment included motor skill acquisition and coordination. Child's behavior was measured by the parent/teacher reported questionnaire (two different versions) of child's adaptive behavior in the school context.
6 secondary outcomes
Parenting
Time frame: at 7 years of age
Child health condition
Time frame: at 7 years of age
Child neurophysiological functions
Time frame: at 7 years of age
Child educational resources
Time frame: at 7 years of age
Child growth-weight
Time frame: at 7 years of age
Child growth-height
Time frame: at 7 years of age
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 9 Aug 2018.
- Individual participant dataSharing planned: No
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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, Sc.D principal investigator
School of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 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 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 neurobehavioral development (time frame: at 7 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2018.