Premature BirthNCT00173108
Early Intervention for Preterm Infants
A study testing clinic-based intervention program and home-based intervention program in people with Premature Birth, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Premature Birth
- What is being tested?
- clinic-based intervention program and home-based intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Oct 2010
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BW below 1,501 gm
- GA under 37 weeks
- Admission to the NICU within the first 7 days of life
- Physiologically stable at PCA 36 weeks as diagnosed by attending physician
- Hospital discharge prior to PCA 40 weeks
- Absence of congenital anomalies and/or severe neonatal diseases
Show all 10Show fewer
- Family residence in the greater Taipei area.
- Birth weight >2,500 g;
- Gestational age within 38-42 weeks,
- Family living in the same geographic region as those of the VLBW preterm infants
Who cannot join
- Severe neonatal diseases included major neurologic abnormalities (such as seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, and grade IV retinopathy of prematurity)
- Necrotizing enterocolitis with colostomy
- Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge
- Serious prenatal or perinatal complications
Trial locations and contacts
1 site in 1 country.
About this study
The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.
The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.
Read the detailed description
Preterm birth with very low birth weight (VLBW) (gestational age <37 weeks and birth weight <1,501 g) is a significant public health problem worldwide. Longitudinal follow-up studies showed that VLBW preterm infants require prolonged hospitalization and are at substantial risk for various morbidities during neonatal period than those born at normal birth weight. Furthermore, approximately 40% of VLBW preterm infants are burden with adverse outcomes from chronic health problems and re-hospitalizations, to lower IQ, developmental delays, behavioral problems, and poor educational achievement. Accumulating data collected in Western developed countries have suggested that comprehensive and intensive early interventions may be beneficial for preterm infants and their families. However, there is little information concerning what early intervention should be attempted for these infants and their families in Taiwan. The purpose of this study is therefore to examine the cost-effectiveness of three early intervention programs i.e., the usual care program, the clinic-based intervention program, and the home-based intervention program for VLBW preterm infants. In a preliminary study, we surveyed the need of intervention services following hospital discharge in VLBW preterm infants (N=69) and their families. All mothers expressed the need of services that 60 (87%) preferred service delivery at home and 9 (13%) preferred service delivery at neonatal follow-up clinic. The intervention services specifically identified were health and respiratory assistance (N=22), feeding assistance (N=17), education of child development skills (N=12), and parent support (N=8). Based on these survey data and the results of previous intervention studies, we will develop in this proposed research project a clinic-based intervention program and a home-based intervention program that have common intervention services but are respectively delivered via clinic visit and home visit. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age.
This will be a four-year research project that employs a single blind, randomized experimental design to examine the efficacy of the early intervention programs for VLBW preterm infants. For the first year, we will develop the clinic-based intervention program and the home-based intervention programs in the actual situations to examine their clinical usefulness. From the second to the fourth year, 180 VLBW preterm infants who are born and admitted to the neonatal intensive care units of National Taiwan University Hospital and MacKay Memorial Hospital will be randomly assigned to the usual care program, the clinic-based intervention program, and the home-based intervention program. Sixty gender and socio-economically matched normal full-term infants will also be included as a comparison group. Child, parenting, and transactions outcomes will be assessed when infants are at 4, 6, 12, 18, and 24 months of corrected age. Child outcomes are measured by health status, growth, neurodevelopment, and neurosensory status; parenting outcomes are measured by maternal parenting competence, social support, and psychological stress; transactions outcome is measured by mother-infant interaction. Generalized estimating equations will be used to examine the differences in changes of outcome variables between intervention and control groups. At the end of the fourth year, the costs and effectiveness of the three intervention programs will be compared to determine which one is more cost-effective for VLBW preterm infants in Taiwan. The results of this study will help clinicians and parents understand the efficacy of early intervention for VLBW preterm infants. Furthermore, the data of this study will provide important information to policy makers and health administrators concerning resource allocation of early intervention forVLBW preterm infants in Taiwan.
- Conditions
- Premature Birth
- Being tested
- clinic-based intervention program and home-based intervention program
- Keywords
- Prematurity, Early intervention, Neurodevelopment, Cost-effectiveness
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinic-based intervention program and home-based intervention programBehavioural
The intervention includes education of child development skills, health and feeding consultation, intervention of mother-infant interaction, and parent support. Clinic-based intervention program is delivered in clinic while home-based intervention program is delivered at home.
| Study group | Role | What they receive |
|---|---|---|
| Term group | No intervention | Not described |
| Usual care program group | No intervention | Not described |
| Clinic-based interveniton program group | Experimental | Not described Receives: Behavioral: clinic-based intervention program and home-based intervention program |
| Home-based interveniton program group | Experimental | Not described Receives: Behavioral: clinic-based intervention program and home-based intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan.
Effectiveness includes the child (health, growth, neurodevelopment, and neurosensory), parent (competence, social support, and psychological stress) and transaction outcomes (parent-child interaction). Cost includes direct and indirect cost related to health and intervention program
Measured: In-hospital, 6, 12, 18 and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University, National Health Research Institutes, Taiwan
- Investigators
- Suh-Fang Jeng, Sc.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173108
- Sponsor's protocol ID
- 9461700406
- Status last verified
- Mar 2011
- First submitted
- 12 Sep 2005
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- 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 35921693Su YH, Jeng SF, Hsieh WS, Tu YK, Wu YT, Chen LC. Gross Motor Trajectories During the First Year of Life for Preterm Infants With Very Low Birth Weight. Phys Ther. 2017 Mar 1;97(3):365-373. doi: 10.1093/ptj/pzx007.
PubMed 28339607Wu YC, Leng CH, Hsieh WS, Hsu CH, Chen WJ, Gau SS, Chiu NC, Yang MC, Li-Jung Fang, Hsu HC, Yu YT, Wu YT, Chen LC, Jeng SF. A randomized controlled trial of clinic-based and home-based interventions in comparison with usual care for preterm infants: effects and mediators. Res Dev Disabil. 2014 Oct;35(10):2384-93. doi: 10.1016/j.ridd.2014.06.009. Epub 2014 Jun 26.
PubMed 24973546
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Preterm Infants
- ClinicalTrials.gov ID
- NCT00173108
- Acronym / sponsor ID
- 9461700406
- Conditions
- Premature Birth
- Keywords
- Prematurity, Early intervention, Neurodevelopment, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University, National Health Research Institutes, Taiwan
- Study start
- Jan 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Sep 2005 (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 first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.
The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.
Detailed description
Preterm birth with very low birth weight (VLBW) (gestational age <37 weeks and birth weight <1,501 g) is a significant public health problem worldwide. Longitudinal follow-up studies showed that VLBW preterm infants require prolonged hospitalization and are at substantial risk for various morbidities during neonatal period than those born at normal birth weight. Furthermore, approximately 40% of VLBW preterm infants are burden with adverse outcomes from chronic health problems and re-hospitalizations, to lower IQ, developmental delays, behavioral problems, and poor educational achievement. Accumulating data collected in Western developed countries have suggested that comprehensive and intensive early interventions may be beneficial for preterm infants and their families. However, there is little information concerning what early intervention should be attempted for these infants and their families in Taiwan. The purpose of this study is therefore to examine the cost-effectiveness of three early intervention programs i.e., the usual care program, the clinic-based intervention program, and the home-based intervention program for VLBW preterm infants. In a preliminary study, we surveyed the need of intervention services following hospital discharge in VLBW preterm infants (N=69) and their families. All mothers expressed the need of services that 60 (87%) preferred service delivery at home and 9 (13%) preferred service delivery at neonatal follow-up clinic. The intervention services specifically identified were health and respiratory assistance (N=22), feeding assistance (N=17), education of child development skills (N=12), and parent support (N=8). Based on these survey data and the results of previous intervention studies, we will develop in this proposed research project a clinic-based intervention program and a home-based intervention program that have common intervention services but are respectively delivered via clinic visit and home visit. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age.
This will be a four-year research project that employs a single blind, randomized experimental design to examine the efficacy of the early intervention programs for VLBW preterm infants. For the first year, we will develop the clinic-based intervention program and the home-based intervention programs in the actual situations to examine their clinical usefulness. From the second to the fourth year, 180 VLBW preterm infants who are born and admitted to the neonatal intensive care units of National Taiwan University Hospital and MacKay Memorial Hospital will be randomly assigned to the usual care program, the clinic-based intervention program, and the home-based intervention program. Sixty gender and socio-economically matched normal full-term infants will also be included as a comparison group. Child, parenting, and transactions outcomes will be assessed when infants are at 4, 6, 12, 18, and 24 months of corrected age. Child outcomes are measured by health status, growth, neurodevelopment, and neurosensory status; parenting outcomes are measured by maternal parenting competence, social support, and psychological stress; transactions outcome is measured by mother-infant interaction. Generalized estimating equations will be used to examine the differences in changes of outcome variables between intervention and control groups. At the end of the fourth year, the costs and effectiveness of the three intervention programs will be compared to determine which one is more cost-effective for VLBW preterm infants in Taiwan. The results of this study will help clinicians and parents understand the efficacy of early intervention for VLBW preterm infants. Furthermore, the data of this study will provide important information to policy makers and health administrators concerning resource allocation of early intervention forVLBW preterm infants in Taiwan.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Term group | No intervention | – |
| Usual care program group | No intervention | – |
| Clinic-based interveniton program group | Experimental | Behavioral: clinic-based intervention program and home-based intervention program |
| Home-based interveniton program group | Experimental | Behavioral: clinic-based intervention program and home-based intervention program |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- BW below 1,501 gm
- GA under 37 weeks
- Admission to the NICU within the first 7 days of life
- Physiologically stable at PCA 36 weeks as diagnosed by attending physician
- Hospital discharge prior to PCA 40 weeks
Key exclusion criteria (4 listed)
- Severe neonatal diseases included major neurologic abnormalities (such as seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, and grade IV retinopathy of prematurity)
- Necrotizing enterocolitis with colostomy
- Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge
- Serious prenatal or perinatal complications
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 |
|---|---|---|
| clinic-based intervention program and home-based intervention programThe intervention includes education of child development skills, health and feeding consultation, intervention of mother-infant interaction, and parent support. Clinic-based intervention program is delivered in clinic while home-based intervention program is delivered at home. | Behavioural | Clinic-based interveniton program group, Home-based interveniton program group |
Primary outcome
Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan.
Time frame: In-hospital, 6, 12, 18 and 24 months of age
Effectiveness includes the child (health, growth, neurodevelopment, and neurosensory), parent (competence, social support, and psychological stress) and transaction outcomes (parent-child interaction). Cost includes direct and indirect cost related to health and intervention program
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 22 Apr 2011.
- 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.
- Derived from this study: PubMed 28339607Su YH, Jeng SF, Hsieh WS, Tu YK, Wu YT, Chen LC. Gross Motor Trajectories During the First Year of Life for Preterm Infants With Very Low Birth Weight. Phys Ther. 2017 Mar 1;97(3):365-373. doi: 10.1093/ptj/pzx007.
- Derived from this study: PubMed 24973546Wu YC, Leng CH, Hsieh WS, Hsu CH, Chen WJ, Gau SS, Chiu NC, Yang MC, Li-Jung Fang, Hsu HC, Yu YT, Wu YT, Chen LC, Jeng SF. A randomized controlled trial of clinic-based and home-based interventions in comparison with usual care for preterm infants: effects and mediators. Res Dev Disabil. 2014 Oct;35(10):2384-93. doi: 10.1016/j.ridd.2014.06.009. Epub 2014 Jun 26.
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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?
A study testing clinic-based intervention program and home-based 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?
The sponsor lists 10 inclusion and 4 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 22 Apr 2011. 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?
Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (time frame: In-hospital, 6, 12, 18 and 24 months 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 NCT00173108, which also lists 3 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 22 Apr 2011.