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Sensorimotor Intervention for Premature Infants

N/A
Waitlist Available
Led By Sandra Fucile, PhD
Research Sponsored by Queen's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants born < 34 weeks gestation
Be younger than 18 years old
Must not have
Infants born with a metabolic disorder or congenital abnormality
Infants whose parents are unable to participate due to cognitive, physical, or social issues.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial will help researchers understand if a parent administered sensorimotor program can improve developmental outcomes in infants born preterm.

Who is the study for?
This trial is for preterm infants born before 34 weeks of gestation whose parents can visit them regularly (more than 5 days). It's not suitable for infants with metabolic disorders, congenital abnormalities, or if their parents have cognitive, physical or social challenges that prevent participation.Check my eligibility
What is being tested?
The study tests a sensorimotor program administered by parents to see if it improves the developmental outcomes of preterm infants. Infants will either receive this intervention or be in a control group without it to compare results.See study design
What are the potential side effects?
Since the intervention involves parent-administered activities designed to aid development, there are no direct medical side effects. However, any unexpected negative reactions observed during the program would be documented.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born before 34 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant was born with a metabolic disorder or a birth defect.
Select...
My infant cannot participate because of my cognitive, physical, or social issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attainment of independent oral feeds
Secondary outcome measures
Acute stress of parents
Length of hospital stay
Test of infant motor performance
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sensorimotor interventionExperimental Treatment2 Interventions
Is a 15-minute intervention consisting of tactile (i.e., stroking the whole body) and oral input (i.e., stroking the oral structures) for 15 minutes duration. The program will start 24 hours after nasal continuous positive airway pressure (NCPAP) is discontinued and 24 hours after 80 ml/kg/day of enteral feeds are tolerated. The program will be administered once a day for 10 days, within a 14-day period. The parents will perform all the interventions in the NICU. The infants will remain in the isolette for the duration of the program. This intervention does not involve any drugs or medical procedures. It is an intervention commonly used by occupational and physical therapists in the neonatal intensive care unit.
Group II: ControlExperimental Treatment1 Intervention
Infants in the control group will receive standard care only.

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor
369 Previous Clinical Trials
121,784 Total Patients Enrolled
Dr. Sandra FucileLead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
Sandra Fucile, PhDPrincipal InvestigatorQueen's University

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT03836326 — N/A
Premature Infants Research Study Groups: Sensorimotor intervention, Control
Premature Infants Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT03836326 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836326 — N/A
~16 spots leftby Jul 2025
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