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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06109350
Other study ID # IRB/Approval/PN/2023/002/564
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2023
Est. completion date December 2024

Study information

Verified date October 2023
Source JDWNRH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 28 Weeks to 34 Weeks
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Supporting play exploration and early developmental intervention(SPEEDI)
SPEEDI will be performed by the parents
Standard care
Standard care will be performed by the parents

Locations

Country Name City State
Bhutan Jigme Dorji Wangchuck National Referral Hospital(JDWNRH) Thimphu

Sponsors (1)

Lead Sponsor Collaborator
JDWNRH

Country where clinical trial is conducted

Bhutan, 

Outcome

Type Measure Description Time frame Safety issue
Other Compare the compliance of the parents Parental compliance will be measured by the ability of the parent to correctly demonstrate the home program activity when they come for follow up visit . 1, 2, and 3 months
Primary 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. 40 weeks, 1, 2, and 3 months of corrected age
Secondary 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. 40 weeks, 1, 2, and 3 months of corrected age
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