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

NCT06109350 | Unknown

• 1 other identifier: IRB/Approval/PN/2023/002/564
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)

  40 weeks, 1, 2, and 3 months of corrected age

Other Outcomes (1)

• Compare the compliance of the parents

  1, 2, and 3 months

Study Arms (2)

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.

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.

Other: Standard care

Interventions

Supporting play exploration and early developmental intervention(SPEEDI) OTHER

SPEEDI will be performed by the parents

Supporting play exploration and early development intervention

Standard care OTHER

Standard care will be performed by the parents

Standard care

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JDWNRH: lead

Study Sites (1)

Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)

Thimphu, 11001, Bhutan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karma Lhaki

  JDWNRH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physiotherapist

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 31, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be maintained securely for at least five years after completion of study and shared.
• Access Criteria: To gain access to data, data requestor can email to principal investigator.

Locations

BH (1)