Child Development, Infant Development, Infant, Premature, Diseases
Conditions
Brief summary
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.
Interventions
BEHAVIORALFinger puppet
The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
BEHAVIORALBookworm reading intervention training and routine EDI care.
Routine EDI care including Bookworm training.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 17 Weeks
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASQ-3 scores | 12 months corrected age | Ages and Stages Questionnaires 3rd Edition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASQ-SE2 scores | 12 months corrected age | Ages and Stages Questionnaires 3rd Edition |
| ASQ-3 scores | 24 months corrected age | Ages and Stages Questionnaires 3rd Edition |
| ASQ scores below -2SD | 12 months corrected age | Ages and Stages Questionnaires 3rd Edition |
| Severe neurodevelopmental impairment | 24 months corrected age | Composite outcome based on BSID scores, GMFCS, Vision, Hearing |
| Moderate or severe neurodevelopmental impairment | 24 months corrected age | Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing |
| ASQ scores below -1SD | 12 months corrected age | Ages and Stages Questionnaires 3rd Edition |
| Language Composite Score on BSID-IV | 24 months corrected age | Bayley's Scales of Infant Development IV language composite score |
| Motor Composite Score on BSID-IV | 24 months corrected age | Bayley's Scales of Infant Development IV motor composite score |
| Edinburgh Postnatal Depression Scale | 6 months | Maternal scores on Edinburgh Postnatal Depression Scale |
| MCHAT score | 24 months corrected age | Modified Checklist for Autism in Toddlers |
| Cognitive Composite Score on BSID-IV | 24 months corrected age | Bayley's Scales of Infant Development IV cognitive composite score |
Countries
United States
Contacts
Primary ContactTamaryn H Garcia
Backup ContactKimberly M Armstead
Outcome results
None listed