Cognitive training for preterm infants using finger puppets
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
This study is testing if using finger puppets in caregiver interactions can help preterm infants develop better communication skills compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 1 Week to 17 Weeks |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06335524 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a caregiver-implemented early developmental intervention (EDI) that utilizes finger puppets to enhance joint attention and interactive communication in preterm infants. The intervention will be compared to routine EDI care that includes Bookworm training alone. The primary outcome measure will be the Ages and Stages Questionnaire® score at 12 months corrected age, assessing the developmental progress of the infants. The study focuses on infants born at less than 34 weeks' gestation who are off sedatives and invasive respiratory support.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at less than 34 weeks' gestation who are currently off sedatives and invasive respiratory support.
Not a fit: Patients with major malformations or known syndromes, or those enrolled in competing trials targeting neurodevelopmental outcomes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive and developmental outcomes for preterm infants.
How similar studies have performed: Other studies have shown promising results with similar caregiver-implemented interventions for preterm infants, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support. Exclusion Criteria: * a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Colm P Travers — University of Alabama at Birmingham
- Study coordinator: Tamaryn H Garcia
- Email: thgarcia@uabmc.edu
- Phone: 2059344680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.