Purpose

This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.

Conditions

Eligibility

Eligible Ages
Between 1 Week and 17 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Caregiver-implemented early developmental intervention (EDI) using finger puppets
Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
  • Behavioral: Finger puppet
    The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
  • Behavioral: Bookworm reading intervention training and routine EDI care.
    Routine EDI care including Bookworm training.
Active Comparator
Routine EDI care including Bookworm training
All study participants will receive Bookworm reading intervention training and routine EDI care.
  • Behavioral: Bookworm reading intervention training and routine EDI care.
    Routine EDI care including Bookworm training.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249
Contact:
Colm P Travers, MD
205-934-4680
ctravers@peds.uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Tamaryn H Garcia
2059344680
thgarcia@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.