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The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants

NCT ID: NCT06109350

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Infant, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Double blinded with the outcome assessor blinded to the group allocation and the parent of preterm infants will be blinded since they will be scheduled for appointment on the different day. The outcome assessor will not be disclosed with the infants information, such as age , any medical diagnosis and group identification.

Study Groups

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Supporting play exploration and early development intervention

Preterm infants will receive supporting play exploration and early developmental intervention till 3 months of corrected age.

Group Type EXPERIMENTAL

Supporting play exploration and early developmental intervention(SPEEDI)

Intervention Type OTHER

SPEEDI will be performed by the parents

Standard care

Preterm infants will receive standard care mostly including health education till 3 months of corrected age.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard care will be performed by the parents

Interventions

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Supporting play exploration and early developmental intervention(SPEEDI)

SPEEDI will be performed by the parents

Intervention Type OTHER

Standard care

Standard care will be performed by the parents

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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JDWNRH

OTHER

Sponsor Role lead

Responsible Party

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Karma Lhaki

Deputy Chief Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karma Lhaki

Role: PRINCIPAL_INVESTIGATOR

JDWNRH

Locations

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Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)

Thimphu, , Bhutan

Site Status

Countries

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Bhutan

Facility Contacts

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Dinesh Pradhan, MD

Role: primary

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IRB/Approval/PN/2023/002/564

Identifier Type: -

Identifier Source: org_study_id