PretermNCT05334550
Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
A study testing Home Based Early Intervention by Parent in people with Preterm and Extreme Prematurity, run by Samsung Medical Center.
Trial summary
This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm, Extreme Prematurity, Early Intervention
- What is being tested?
- Home Based Early Intervention by Parent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2022to 2 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Extreme premature baby (gestationl age 23~28 weeks)
- Corrected age under one month at the time of enroll of this study
- Children of those who voluntarily decided to participate after hearing detailed explanations about this study and gave their written consent.
- Children whose parents are Korean
Who cannot join
- Congenital anomalies in the central nervous system
- Hereditary diseases
- Chromosomal abnormalities (Down syndrome, etc.)
- Stage 3 or more intraventricular hemorrhage
- If surgery was performed for hydrocephalus
- Leukomalacia confirmed by ultrasound examination (not applicable to increase in white matter shading)
Show all 19Show fewer
- Neonatal asphyxia
- Other central nervous system diseases
- If taking medications for convulsions or epilepsy
- Metabolic disease
- In the case of premature infants undergoing surgery for retinal disease
- Hearing loss
- In case of surgery due to complex congenital anomaly or planned operation (not excluded if surgery is not required)
- In case of oxygen dependence due to lung disease in premature infants
- Musculoskeletal disorders (hip dislocation, polyarthrosis, etc.)
- Neuromuscular disease, etc.
- Those whose family has social problems
- Those whose parents cannot participate in this study
- Those who have other serious complications that cannot proceed with the study
Trial locations and contacts
No sites are listed yet.
About this study
This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.
Read the detailed description
The perpose of this study to prove the significance of the hypothesis that there will be a significant improvement in motor development when remote tele-rehabilitation treatment is performed for extremely premature infants. The investigators plan to recruit subjects who meet the inclusion criteria and do not meet the exclusion criteria from among extremely premature infants born at Samsung Hospital, Seoul, Korea, whose gestational age is from 23 weeks to 28 weeks. The target number of n is 110, 55 per group. After randomization into an intervention group and a control group, the intervention group get the intervention starting at 0 months of correctional age and runs for 3 months. In both groups, motor outcomes are measured at the time of enrollment, at 3 months of correction age, 6 months of correction age and 12 months of correction age
- Conditions
- Preterm, Extreme Prematurity, Early Intervention, Developmental Delay, Motor Outcome, Home Exercise
- Being tested
- Home Based Early Intervention by Parent
- Medical subject headings
- Premature Birth, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Early Intervention by ParentOther
Through a video communication program called ZOOM, the parents of intervention group are educated once every two weeks for three months. Parent education consists of a program developed by our pediatric rehabilitation therapist to help premature infants develop motor skills. Parents provide daily exercise training to their children as educated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Allocated to intervention group through randomization process. Receives: Other: Home Based Early Intervention by Parent |
| Control group | No intervention | Allocated to control group through randomization process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Test of infant motor performance at 3 months
The Test of infant motor performance (TIMP) is conducted on infants under 4 months of age to perform functions in daily life. It is performed to evaluate the selective control of postures and movements that infants need in daily life, and takes an average of 25-35 minutes. The TIMP was developed to 1) identify infants with delayed motor development, 2) differentiate between infants with varying degrees of risk for measurement outcomes, and 3) measure changes due to interventions. Because it can be used in both early intervention programs, it can aid in communication between parents and health care providers in a variety of settings. The range of test score is from 0 to 142. The higher score means the better motor performance.
Measured: around the start of intervention(up to 1 week), 3 months after the start of intervetion
Secondary outcomes (3)
Change from baseline Edinburgh postnatal depression scale at 3 months
Edinburgh postnatal depression scale is a 10-item scale for screening for maternal depression. Each item is scored from 0 to 3; the higher score indicates the possibility of depressed status. Total score is from 0 to 30. A score of 13 or higher indicates a possible postpartum depression. It has been validated by several studies confirming that EPDS is a reliable and sensitive indicator of depression.
Measured: around the start of intervention(up to 1 week), 3 months after the start of intervetion
Alberta infant motor scale
Alberta infant motor scale is a validated and reliable observational tool for use in infants from full term to 18 months of age. Alberta infant motor scale can evaluate the qualitative aspects of movement and sensitively measure the change in infant's motor performance. Assessment of Alberta infant motor scale is scored based on the number of gross motor postures and movements the infant has demonstrated while prone, supine, and sitting or standing. The range of scores of each item are as followed; prone is from 0 to 21, supine is from 0 to 9, sitting is from 0 to 12, standing is from 0 to 16. The range of total score is from 0 to 58. The higher score means the better motor performance. The evaluation score can be converted to a percentile rank that can be compared with the percentile rank of a standard age-matched infant sample.
Measured: 6 months and 12 months after the start of intervetion
Peabody Developmental Motor Scales 2nd edition
Peabody Developmental Motor Scales 2nd edition evaluates both fine motor and macromotor function. It can be evaluated from newborn to 5 years old. It consists of six subtests: reflex, stationary, locomotion, object manipulation, grasping, and visual motor integration. Range of score of each items are as followed; reflex is from 0 to 16, stationary is from 0 to 60, locomotion is from 0 to 198, objective manipulation is from 0 to 48, grasping is from 0 to 26, visual-motor integration is from 0 to 72. The summation of scores is converted into age-matched percentile that can be ranked. The higher scores is matched to better ranked percentile. Peabody Developmental Motor Scales 2nd edition is a test whose reliability and validity have been verified in various conditions such as autism, cerebral palsy, and premature infants.
Measured: 12 months after the start of intervetion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start2 Jun 2022 (estimated)
- Primary completion2 Mar 2023 (estimated)
- Study completion2 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
- Investigators
- Kwon Jeong-Yi, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334550
- Sponsor's protocol ID
- 2022-02-28
- Status last verified
- Jun 2022
- First submitted
- 2 Mar 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
통계청, 『2019년 출생통계(확정), 국가승인통계 제10103호 출생통계』
McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008 Jan;111(1):35-41. doi: 10.1097/01.AOG.0000297311.33046.73.
PubMed 18165390Morgan AM, Koch V, Lee V, Aldag J. Neonatal neurobehavioral examination. A new instrument for quantitative analysis of neonatal neurological status. Phys Ther. 1988 Sep;68(9):1352-8. doi: 10.1093/ptj/68.9.1352.
PubMed 3420169Piper MC, Darrah J. Motor Assessment of the Developing Infant. Philadelphia: WB Saunders; 1994.
Aita M, De Clifford Faugere G, Lavallee A, Feeley N, Stremler R, Rioux E, Proulx MH. Effectiveness of interventions on early neurodevelopment of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 29;21(1):210. doi: 10.1186/s12887-021-02559-6.
PubMed 33926417Fernández Rego Francisco Javier, Gómez Conesa Antonia, Pérez López Julio, Efficacy of Early Physiotherapy Intervention in Preterm Infant Motor Development- A Systematic Review-, Journal of Physical Therapy Science, 2012, Volume 24, Issue 9, Pages 933-940, Released December 01, 2012, Online ISSN 2187-5626, Print ISSN 0915-5287
Puthussery S, Chutiyami M, Tseng PC, Kilby L, Kapadia J. Effectiveness of early intervention programs for parents of preterm infants: a meta-review of systematic reviews. BMC Pediatr. 2018 Jul 9;18(1):223. doi: 10.1186/s12887-018-1205-9.
PubMed 29986683Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.
PubMed 26597166배영임, 신혜리. 코로나19, 언택트 사회를 가속화하다. 이슈&진단 . (2020): 1-26.
Campbell SK, Wright BD, Linacre JM. Development of a functional movement scale for infants. J Appl Meas. 2002;3(2):190-204.
PubMed 12011500Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Boyce P, Stubbs J, Todd A. The Edinburgh Postnatal Depression Scale: validation for an Australian sample. Aust N Z J Psychiatry. 1993 Sep;27(3):472-6. doi: 10.3109/00048679309075805.
PubMed 8250792Milgrom J, Ericksen J, Negri L, Gemmill AW. Screening for postnatal depression in routine primary care: properties of the Edinburgh Postnatal Depression Scale in an Australian sample. Aust N Z J Psychiatry. 2005 Sep;39(9):833-9. doi: 10.1080/j.1440-1614.2005.01660.x.
PubMed 16168042Piper MC, Pinnell LE, Darrah J, Maguire T, Byrne PJ. Construction and validation of the Alberta Infant Motor Scale (AIMS). Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S46-50.
PubMed 1468050Martin T. Stein, Meghan Korey Lukasik, Chapter 79 - DEVELOPMENTAL SCREENING AND ASSESSMENT: INFANTS, TODDLERS, AND PRESCHOOLERS, Editor(s): William B. Carey, Allen C. Crocker, William L. Coleman, Ellen Roy Elias, Heidi M. Feldman, Developmental-Behavioral Pediatrics (Fourth Edition), W.B. Saunders, 2009, Pages 785-796,
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
- ClinicalTrials.gov ID
- NCT05334550
- Acronym / sponsor ID
- 2022-02-28
- Conditions
- Preterm, Extreme Prematurity, Early Intervention, Developmental Delay, Motor Outcome, Home Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2022 (estimated)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 2 Mar 2024 (estimated)
- First posted
- 19 Apr 2022 (actual)
- 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 study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.
Detailed description
The perpose of this study to prove the significance of the hypothesis that there will be a significant improvement in motor development when remote tele-rehabilitation treatment is performed for extremely premature infants. The investigators plan to recruit subjects who meet the inclusion criteria and do not meet the exclusion criteria from among extremely premature infants born at Samsung Hospital, Seoul, Korea, whose gestational age is from 23 weeks to 28 weeks. The target number of n is 110, 55 per group. After randomization into an intervention group and a control group, the intervention group get the intervention starting at 0 months of correctional age and runs for 3 months. In both groups, motor outcomes are measured at the time of enrollment, at 3 months of correction age, 6 months of correction age and 12 months of correction age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Home Based Early Intervention by ParentAllocated to intervention group through randomization process. |
| Control group | No intervention | –Allocated to control group through randomization process. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Extreme premature baby (gestationl age 23~28 weeks)
- Corrected age under one month at the time of enroll of this study
- Children of those who voluntarily decided to participate after hearing detailed explanations about this study and gave their written consent.
- Children whose parents are Korean
Key exclusion criteria (19 listed)
- Congenital anomalies in the central nervous system
- Hereditary diseases
- Chromosomal abnormalities (Down syndrome, etc.)
- Stage 3 or more intraventricular hemorrhage
- If surgery was performed for hydrocephalus
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 Early Intervention by ParentThrough a video communication program called ZOOM, the parents of intervention group are educated once every two weeks for three months. Parent education consists of a program developed by our pediatric rehabilitation therapist to help premature infants develop motor skills. Parents provide daily exercise training to their children as educated. | Other | Intervention group |
Primary outcome
Change from baseline Test of infant motor performance at 3 months
Time frame: around the start of intervention(up to 1 week), 3 months after the start of intervetion
The Test of infant motor performance (TIMP) is conducted on infants under 4 months of age to perform functions in daily life. It is performed to evaluate the selective control of postures and movements that infants need in daily life, and takes an average of 25-35 minutes. The TIMP was developed to 1) identify infants with delayed motor development, 2) differentiate between infants with varying degrees of risk for measurement outcomes, and 3) measure changes due to interventions. Because it can be used in both early intervention programs, it can aid in communication between parents and health care providers in a variety of settings. The range of test score is from 0 to 142. The higher score means the better motor performance.
3 secondary outcomes
Change from baseline Edinburgh postnatal depression scale at 3 months
Time frame: around the start of intervention(up to 1 week), 3 months after the start of intervetion
Alberta infant motor scale
Time frame: 6 months and 12 months after the start of intervetion
Peabody Developmental Motor Scales 2nd edition
Time frame: 12 months after the start of intervetion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background통계청, 『2019년 출생통계(확정), 국가승인통계 제10103호 출생통계』
- Background: PubMed 18165390McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008 Jan;111(1):35-41. doi: 10.1097/01.AOG.0000297311.33046.73.
- Background: PubMed 3420169Morgan AM, Koch V, Lee V, Aldag J. Neonatal neurobehavioral examination. A new instrument for quantitative analysis of neonatal neurological status. Phys Ther. 1988 Sep;68(9):1352-8. doi: 10.1093/ptj/68.9.1352.
- BackgroundPiper MC, Darrah J. Motor Assessment of the Developing Infant. Philadelphia: WB Saunders; 1994.
- Background: PubMed 33926417Aita M, De Clifford Faugere G, Lavallee A, Feeley N, Stremler R, Rioux E, Proulx MH. Effectiveness of interventions on early neurodevelopment of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 29;21(1):210. doi: 10.1186/s12887-021-02559-6.
- BackgroundFernández Rego Francisco Javier, Gómez Conesa Antonia, Pérez López Julio, Efficacy of Early Physiotherapy Intervention in Preterm Infant Motor Development- A Systematic Review-, Journal of Physical Therapy Science, 2012, Volume 24, Issue 9, Pages 933-940, Released December 01, 2012, Online ISSN 2187-5626, Print ISSN 0915-5287
- Background: PubMed 29986683Puthussery S, Chutiyami M, Tseng PC, Kilby L, Kapadia J. Effectiveness of early intervention programs for parents of preterm infants: a meta-review of systematic reviews. BMC Pediatr. 2018 Jul 9;18(1):223. doi: 10.1186/s12887-018-1205-9.
- Background: PubMed 26597166Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.
- Background배영임, 신혜리. 코로나19, 언택트 사회를 가속화하다. 이슈&진단 . (2020): 1-26.
- Background: PubMed 12011500Campbell SK, Wright BD, Linacre JM. Development of a functional movement scale for infants. J Appl Meas. 2002;3(2):190-204.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 8250792Boyce P, Stubbs J, Todd A. The Edinburgh Postnatal Depression Scale: validation for an Australian sample. Aust N Z J Psychiatry. 1993 Sep;27(3):472-6. doi: 10.3109/00048679309075805.
- 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.
Kwon Jeong-Yi, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Early Intervention by Parent in people with Preterm and Extreme Prematurity, run by Samsung Medical Center.
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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Jinuk, resident (+8210-4555-3349, jinuk8780.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Test of infant motor performance at 3 months (time frame: around the start of intervention(up to 1 week), 3 months after the start of intervetion). 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 NCT05334550, which also lists 20 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 8 Jun 2022.