Premature BirthNCT00946244
A Longitudinal Study of Effectiveness of Early Intervention for Preterm Infants
An observational study of Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The main purpose of this study is to extend the investigators' previous research to longitudinally examine the effectiveness of three early intervention programs: usual care program, clinic-based intervention program and home-based intervention program for very low birth weight preterm children at 3 and 4 years of… Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- How many people
- 183 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to Aug 2012
- 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 3 to 4 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)
Who may be able to join
- Body weight below 1501 gm
- Gestational age under 37 weeks
- Admission to the study hospitals within the first 7 days of life
- Singleton or the first child of twin or multiple births
- Physiologically stable at PCA 36 weeks as determined by attending physician
- Hospital discharge prior to PCA 44 weeks
Who cannot join
- Seizure
- Hydrocephalus
- Ventriculoperitoneal shunt
- Meningitis, periventricular leukomalacia
- Grade III to IV intraventricular hemorrhage
- Stage IV retinopathy of prematurity)
- Necrotizing enterocolitis with colostomy
- Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to extend the investigators' previous research to longitudinally examine the effectiveness of three early intervention programs: usual care program, clinic-based intervention program and home-based intervention program for very low birth weight preterm children at 3 and 4 years of age. Normal weight full-term children will also be included to serve as the reference group. Effectiveness assessments will include child, parenting, and transactions measures. Child outcome measures will include health status, growth, neurodevelopment and behavior; parenting outcome measures will include parental stress, competence, efficacy and family support; transactions outcome measure will include parent-child interaction procedures.
Read the detailed description
Accumulating data on early intervention for preterm infants illustrated short-term benefits on enhancing child development and decreasing parental stress, particularly for those of heavier birth weights. However, rare studies had designed early intervention program for small preterm infants and longitudinally examined the effectiveness in various outcome domains. Our research team recently conducted a clinical randomization trial on the effectiveness of three early intervention programs: usual care program (UCP), clinic-based intervention program (CBIP) and home-based intervention program (HBIP) on very low birth weight (VLBW, birth weight <1,500 g) preterm infants from the neonatal period to two years corrected age (CA). The latter two were comprehensive, intensive intervention programs that combined child- and parent-focused services beginning in hospitalization and ending at one year CA as delivered at clinic and home respectively. This three-year research project has extended our previous work to longitudinally examine the effectiveness of the three intervention programs in 180 VLBW preterm infants at 3 and 4 years of age. Sixty full-term infants will also be included to serve as the reference group. Outcome measures will include child (i.e., health, growth, neurodevelopment and behavior), parenting (i.e., parental stress, competency, efficacy and family support) and mother-child transactions (i.e., free-play and frustrating episode). The longitudinal data on the effectiveness of these early intervention programs for VLBW preterm infants will provide important information to help early intervention professionals and public policy makers to develop effective intervention for preterm children at risk for developmental problems.
- Conditions
- Premature Birth
- Keywords
- Early intervention, Mother-child interaction, Neurodevelopment, Parenting, 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.
| Study group | Role | What they receive |
|---|---|---|
| Term infants | Healthy term infants | |
| Usual care program | VLBW preterm infants who received usual medical care during hospitalization after birth | |
| Clinic-based intervention program | VLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in previous study) | |
| Home-based intervention program | VLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in previous study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's development (health, growth, neurodevelopment and behavior)
Measured: 3 and 4 years of age
Secondary outcomes (2)
Parenting function (parent stress, competency, efficacy and family support)
Measured: 3 and 4 years of age
Parent-child transactions
Measured: 3 and 4 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 posted24 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionAug 2012
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suh-Fang Jeng, Sc.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946244
- Sponsor's protocol ID
- 200812114R
- Status last verified
- Nov 2009
- First submitted
- 22 Jul 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Effectiveness of Early Intervention for Preterm Infants
- ClinicalTrials.gov ID
- NCT00946244
- Acronym / sponsor ID
- 200812114R
- Conditions
- Premature Birth
- Keywords
- Early intervention, Mother-child interaction, Neurodevelopment, Parenting, Prematurity, Preschool age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Jul 2009 (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.
The main purpose of this study is to extend the investigators' previous research to longitudinally examine the effectiveness of three early intervention programs: usual care program, clinic-based intervention program and home-based intervention program for very low birth weight preterm children at 3 and 4 years of age. Normal weight full-term children will also be included to serve as the reference group. Effectiveness assessments will include child, parenting, and transactions measures. Child outcome measures will include health status, growth, neurodevelopment and behavior; parenting outcome measures will include parental stress, competence, efficacy and family support; transactions outcome measure will include parent-child interaction procedures.
Detailed description
Accumulating data on early intervention for preterm infants illustrated short-term benefits on enhancing child development and decreasing parental stress, particularly for those of heavier birth weights. However, rare studies had designed early intervention program for small preterm infants and longitudinally examined the effectiveness in various outcome domains. Our research team recently conducted a clinical randomization trial on the effectiveness of three early intervention programs: usual care program (UCP), clinic-based intervention program (CBIP) and home-based intervention program (HBIP) on very low birth weight (VLBW, birth weight <1,500 g) preterm infants from the neonatal period to two years corrected age (CA). The latter two were comprehensive, intensive intervention programs that combined child- and parent-focused services beginning in hospitalization and ending at one year CA as delivered at clinic and home respectively. This three-year research project has extended our previous work to longitudinally examine the effectiveness of the three intervention programs in 180 VLBW preterm infants at 3 and 4 years of age. Sixty full-term infants will also be included to serve as the reference group. Outcome measures will include child (i.e., health, growth, neurodevelopment and behavior), parenting (i.e., parental stress, competency, efficacy and family support) and mother-child transactions (i.e., free-play and frustrating episode). The longitudinal data on the effectiveness of these early intervention programs for VLBW preterm infants will provide important information to help early intervention professionals and public policy makers to develop effective intervention for preterm children at risk for developmental problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Term infants | – | –Healthy term infants |
| Usual care program | – | –VLBW preterm infants who received usual medical care during hospitalization after birth |
| Clinic-based intervention program | – | –VLBW preterm infants who received specific early intervention program delivered at clinic before 1 year of corrected age (in previous study) |
| Home-based intervention program | – | –VLBW preterm infants who received specific early intervention program delivered at home before 1 year of corrected age (in previous study) |
Who may qualify
- Ages
- 3 to 4 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)
Key inclusion criteria (6 listed)
- Body weight below 1501 gm
- Gestational age under 37 weeks
- Admission to the study hospitals within the first 7 days of life
- Singleton or the first child of twin or multiple births
- Physiologically stable at PCA 36 weeks as determined by attending physician
Key exclusion criteria (8 listed)
- Seizure
- Hydrocephalus
- Ventriculoperitoneal shunt
- Meningitis, periventricular leukomalacia
- Grade III to IV intraventricular hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child's development (health, growth, neurodevelopment and behavior)
Time frame: 3 and 4 years of age
2 secondary outcomes
Parenting function (parent stress, competency, efficacy and family support)
Time frame: 3 and 4 years of age
Parent-child transactions
Time frame: 3 and 4 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 23 Feb 2017.
- 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.
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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
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?
The sponsor lists 6 inclusion and 8 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 23 Feb 2017. 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's development (health, growth, neurodevelopment and behavior) (time frame: 3 and 4 years of 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 NCT00946244, 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 23 Feb 2017.