Very Low Birth Weight InfantsNCT02415530
Early Family Based Intervention in Preterm Infants
A study testing Combined home visiting and group intervention in people with Very Low Birth Weight Infants, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Infants
- What is being tested?
- Combined home visiting and group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Mar 2015to 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preterm infants < 32 weeks of gestation or 1,500 gm of birth weight
- normal term infants
Who cannot join
- major congenital anomaly
- neuromuscular disease
- chromosomal anomaly
- triplets or more multiplets
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
CHA Gangnam Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
About this study
Official title: Early Family-Based Intervention for Developmental Enforcement of Premature Infants
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.
- Conditions
- Very Low Birth Weight Infants
- Being tested
- Combined home visiting and group intervention, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined home visiting and group interventionBehavioural
home visit includes pre-discharge meeting with parents; education of appropriate feeding, breastfeeding, sleeping, position of baby, defecation, environment for baby care and resuscitation on emergency situation first visit (5 days after discharge); understanding baby's sign check feeding, sleeping, sanitation, defecation, environment second visit (14 days after discharge); understanding baby's sign and baby's development support parents check feeding, sleeping, sanitation, defecation, environment special situation third visit (4 weeks after discharge) understanding baby's sign and baby's development support parents special situation fourth visit (8 weeks after discharge) same as third visit Group intervention for parental support with baby 12 times during corrected age 3~6 months
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Term infant control | Placebo comparator | term infant without intervention Receives: Other: No intervention |
| VLBW infant control | Placebo comparator | very low birth weight infant without intervention Receives: Other: No intervention |
| VLBW infant intervention | Experimental | Combined home visiting and group intervention for very low birth weight infant Receives: Behavioral: Combined home visiting and group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development III, mental developmental index
Measured: Corrected age 10 months
Secondary outcomes (6)
Bayley Scales of Infant and Toddler Development III, psychomotor developmental index
Measured: Corrected age 10 month
CES-D-depression screening tool
Measured: Corrected age 2 month & 6 month
Maternal attachment
Measured: Corrected age 2 month & 6 month
Temperament scale
Measured: Corrected age 8 month
Wechsler Intelligence Scale
Measured: 8 years of age
Conners ADHD/DSM-IV Scales
Measured: 8 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 posted14 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2016
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantsStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, CHA University
- Responsible party
- Principal investigator, Ee-Kyung Kim, Seoul National University Hospital
- Investigators
- Ee-kyung Kim, Principal investigator, Seoun National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415530
- Sponsor's protocol ID
- 1501097642
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Family-Based Intervention for Developmental Enforcement of Premature Infants
- ClinicalTrials.gov ID
- NCT02415530
- Acronym / sponsor ID
- 1501097642
- Conditions
- Very Low Birth Weight Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, CHA University
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 14 Apr 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.
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Term infant control | Placebo comparator | Other: No interventionterm infant without intervention |
| VLBW infant control | Placebo comparator | Other: No interventionvery low birth weight infant without intervention |
| VLBW infant intervention | Experimental | Behavioral: Combined home visiting and group interventionCombined home visiting and group intervention for very low birth weight infant |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm infants < 32 weeks of gestation or 1,500 gm of birth weight
- normal term infants
Key exclusion criteria (4 listed)
- major congenital anomaly
- neuromuscular disease
- chromosomal anomaly
- triplets or more multiplets
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 |
|---|---|---|
| Combined home visiting and group interventionhome visit includes pre-discharge meeting with parents; education of appropriate feeding, breastfeeding, sleeping, position of baby, defecation, environment for baby care and resuscitation on emergency situation first visit (5 days after discharge); understanding baby's sign check feeding, sleeping, sanitation, defecation, environment second visit (14 days after discharge); understanding baby's sign and baby's development support parents check feeding, sleeping, sanitation, defecation, environment special situation third visit (4 weeks after discharge) understanding baby's sign and baby's development support parents special situation fourth visit (8 weeks after discharge) same as third visit Group intervention for parental support with baby 12 times during corrected age 3~6 months | Behavioural | VLBW infant intervention |
| No interventionNo intervention | Other | Term infant control, VLBW infant control |
Primary outcome
Bayley Scales of Infant and Toddler Development III, mental developmental index
Time frame: Corrected age 10 months
6 secondary outcomes
Bayley Scales of Infant and Toddler Development III, psychomotor developmental index
Time frame: Corrected age 10 month
CES-D-depression screening tool
Time frame: Corrected age 2 month & 6 month
Maternal attachment
Time frame: Corrected age 2 month & 6 month
Temperament scale
Time frame: Corrected age 8 month
Wechsler Intelligence Scale
Time frame: 8 years of age
Conners ADHD/DSM-IV Scales
Time frame: 8 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 4 Apr 2019.
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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.
Ee-kyung Kim principal investigator
Seoun National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined home visiting and group intervention in people with Very Low Birth Weight Infants, run by Seoul National University Hospital at 3 sites in South Korea.
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 2 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?
Bayley Scales of Infant and Toddler Development III, mental developmental index (time frame: Corrected age 10 months). 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 4 Apr 2019.