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Sensorimotor Intervention for Premature Infants

Q: Does this clinical trial currently have any open spots for participants?

<p>Affirmative, the information available on clinicaltrials.gov implies that this medical investigation is currently recruiting volunteers. This trial was first posted in July 2019 and amended most recently in September 2022; it seeks 84 participants from one site.</p>

Q: What is the enrolled participant count for this trial?

<p>Affirmative. According to information on clinicaltrials.gov, this experiment is still looking for participants since it was first posted in July 2019 and recently updated in September 2022. In total, 84 subjects must be enrolled at a single medical facility.</p>

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Length of hospital stay

Test of infant motor performance

Weight gain

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sensorimotor interventionExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor

365 Previous Clinical Trials

120,333 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently have any open spots for participants?

"Affirmative, the information available on clinicaltrials.gov implies that this medical investigation is currently recruiting volunteers. This trial was first posted in July 2019 and amended most recently in September 2022; it seeks 84 participants from one site."

Answered by AI

What is the enrolled participant count for this trial?

"Affirmative. According to information on clinicaltrials.gov, this experiment is still looking for participants since it was first posted in July 2019 and recently updated in September 2022. In total, 84 subjects must be enrolled at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

Dr. Sandra Fucile 2019. "A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836326.