Infant, PrematureNCT06109350
The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants
A study testing Supporting play exploration and early developmental intervention(SPEEDI) in people with Infant, Premature, run by JDWNRH at 1 site in Bhutan.
Trial summary
The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is: Will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected… Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Supporting play exploration and early developmental intervention(SPEEDI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBhutan
- Study dates
- Oct 2023to Dec 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 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born between 28 -34 weeks of gestation
- Medically stable and off ventilator at the time of discharge from the hospital
- Parents who consent to come for follow up
Who cannot join
- Cortical blindness or retinopathy of prematurity causing blindness
- Musculoskeletal/congenital abnormalities
- Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus
- Genetic syndrome
- Family who do not consent
- Parent with physical and psychological problems
- Infants with medical devices such as NG tube and gastrostomy
- Infants who have undergone major surgery
Trial locations and contacts
1 site in 1 country.
Bhutan1 site
Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)
Thimphu, 11001
Dinesh Pradhan, MD, +97517999472, dinesh.bhutan@gmail.com
Karma Lhaki, MSc
About this study
Official title: The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial
The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is:
Will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? In this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.
Read the detailed description
After receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age.
The preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(SPEEDI) and the standard group will receive standard care. The intervention for both groups will be provided by the physical therapists. The SPEEDI intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. The parent will be asked to bring the infants for monthly follow up.
The motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. The measurement tool that will be used to assess the preterm infants are Test for Infant Motor Performance(TIMP) and Rapid Neurodevelopment Assessment(RNDA). The assessment will be performed by therapist who will be blinded to the group allocation.
The end point of the study is at 3 months of corrected age.
- Conditions
- Infant, Premature
- Being tested
- Supporting play exploration and early developmental intervention(SPEEDI), Standard care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting play exploration and early developmental intervention(SPEEDI)Other
SPEEDI will be performed by the parents
Standard careOther
Standard care will be performed by the parents
| Study group | Role | What they receive |
|---|---|---|
| Supporting play exploration and early development intervention | Experimental | Preterm infants will receive supporting play exploration and early developmental intervention till 3 months of corrected age. Receives: Other: Supporting play exploration and early developmental intervention(SPEEDI) |
| Standard care | Active comparator | Preterm infants will receive standard care mostly including health education till 3 months of corrected age. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the motor performance using Test for Infant Motor Performance(TIMP)
TIMP is a validated tool to measure the motor performance from 34 weeks post menstrual age through 4 months corrected age. The 42 items on the test provides comprehensive assessment of head and trunk control and arms and legs movement. The total score of TIMP ranges from 0-142 with higher scores representing better motor outcome and lower score representing motor delay.
Measured: 40 weeks, 1, 2, and 3 months of corrected age
Secondary outcomes (1)
Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)
RNDA is a validated tool to assess the neurodevelopment from birth to 2 years. It used to assess developmental domains such as primitive reflex, gross motor, fine motor, vision, hearing, speech, cognition and behavior. The assessment can be interpreted into four categories which are no, mild, moderate and severe impairment.
Measured: 40 weeks, 1, 2, and 3 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JDWNRH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karma Lhaki, JDWNRH
- Investigators
- Karma Lhaki, Principal investigator, JDWNRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109350
- Sponsor's protocol ID
- IRB/Approval/PN/2023/002/564
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be shared after de identification
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06109350
- Acronym / sponsor ID
- IRB/Approval/PN/2023/002/564
- Conditions
- Infant, Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- JDWNRHUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Oct 2023 (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.
The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is:
Will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? In this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.
Detailed description
After receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age.
The preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(SPEEDI) and the standard group will receive standard care. The intervention for both groups will be provided by the physical therapists. The SPEEDI intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. The parent will be asked to bring the infants for monthly follow up.
The motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. The measurement tool that will be used to assess the preterm infants are Test for Infant Motor Performance(TIMP) and Rapid Neurodevelopment Assessment(RNDA). The assessment will be performed by therapist who will be blinded to the group allocation.
The end point of the study is at 3 months of corrected age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supporting play exploration and early development intervention | Experimental | Other: Supporting play exploration and early developmental intervention(SPEEDI)Preterm infants will receive supporting play exploration and early developmental intervention till 3 months of corrected age. |
| Standard care | Active comparator | Other: Standard carePreterm infants will receive standard care mostly including health education till 3 months of corrected age. |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born between 28 -34 weeks of gestation
- Medically stable and off ventilator at the time of discharge from the hospital
- Parents who consent to come for follow up
Key exclusion criteria (8 listed)
- Cortical blindness or retinopathy of prematurity causing blindness
- Musculoskeletal/congenital abnormalities
- Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus
- Genetic syndrome
- Family who do not consent
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 |
|---|---|---|
| Supporting play exploration and early developmental intervention(SPEEDI)SPEEDI will be performed by the parents | Other | Supporting play exploration and early development intervention |
| Standard careStandard care will be performed by the parents | Other | Standard care |
Primary outcome
Compare the motor performance using Test for Infant Motor Performance(TIMP)
Time frame: 40 weeks, 1, 2, and 3 months of corrected age
TIMP is a validated tool to measure the motor performance from 34 weeks post menstrual age through 4 months corrected age. The 42 items on the test provides comprehensive assessment of head and trunk control and arms and legs movement. The total score of TIMP ranges from 0-142 with higher scores representing better motor outcome and lower score representing motor delay.
1 secondary outcome
Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)
Time frame: 40 weeks, 1, 2, and 3 months of corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes. Participant data will be shared after de identification
Related trials for Infant, Premature
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)
Thimphu, Bhutan
Karma Lhaki principal investigator
JDWNRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting play exploration and early developmental intervention(SPEEDI) in people with Infant, Premature, run by JDWNRH at 1 site in Bhutan.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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 Bhutan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the motor performance using Test for Infant Motor Performance(TIMP) (time frame: 40 weeks, 1, 2, and 3 months of corrected 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 31 Oct 2023.