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Behavioral Intervention
Pacifier Activated Music Player for Infant Heart Conditions
N/A
Waitlist Available
Led By Nathalie Maitre, MD. PhD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twelve months
Awards & highlights
Study Summary
This trial will test if teaching an infant with a heart condition to suck on a pacifier will help them learn to eat solid foods.
Who is the study for?
This trial is for infants with complex congenital heart defects who are scheduled for surgery and meet specific feeding guidelines. It includes those with acquired brain injury and whose mothers speak languages other than English. However, it excludes infants on assisted ventilation or continuous positive airway pressure, recently under general anesthesia, or with lethal abnormalities or brain malformations.Check my eligibility
What is being tested?
The study tests if using a pacifier activated music player that plays the mother's voice can improve feeding outcomes in these infants by training their non-nutritive sucking—a vital oral motor skill necessary for proper feeding.See study design
What are the potential side effects?
Since this intervention involves non-invasive stimulation through sound and does not include medication or surgical procedures, significant side effects are not anticipated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ twelve months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twelve months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oral feeding Efficiency
Secondary outcome measures
Neurodevelopment
Oral feeding development
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment prior to surgeryExperimental Treatment1 Intervention
Infants randomized to receive the pacifier activated music player and mother's voice treatment prior to surgery for 5 sessions, and mother's voice playing freely post surgery.
Group II: Treatment post surgeryExperimental Treatment1 Intervention
Infants randomized to receive the mother's voice playing freely prior to surgery,and pacifier activated music player and mother's voice treatment post surgery for 5 sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pacifier activated music player
2016
N/A
~70
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,445 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,769 Total Patients Enrolled
Nathalie Maitre, MD. PhDPrincipal InvestigatorPerinatal Research Institute, Nationwide Children's Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical experiment accept volunteers below the age of 30?
"The requirements for this research study include that the applicant must be between 0 and 6 months old. There are 114 trials available to minors, as well as 112 specifically designed for geriatric patients."
Answered by AI
Is there any capacity for me to join this clinical experiment?
"This research project requires infants from 0 to 6 months with heart malformations. 61 participants are expected for the duration of this experiment."
Answered by AI
Are there vacancies for participants in this clinical experiment?
"According to information on clinicaltrials.gov, this medical trial has not been actively recruiting patients since May 31st 2022 and the original posting was made four years prior. Fortunately, there are 200 other trials currently searching for participants."
Answered by AI
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