Clinical trial NCT06109350: The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants
Official title: The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infant, Premature
Lead sponsor: JDWNRH
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 28
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the motor performance using Test for Infant Motor Performance(TIMP)
timeFrame: 40 weeks, 1, 2, and 3 months of corrected age
Secondary outcomes:
measure: Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)
timeFrame: 40 weeks, 1, 2, and 3 months of corrected age
Other outcomes:
measure: Compare the compliance of the parents
timeFrame: 1, 2, and 3 months
Locations:
city: Thimphu
country: Bhutan
facility: Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)
Study officials:
affiliation: JDWNRH
name: Karma Lhaki
role: PRINCIPAL_INVESTIGATOR
References: