Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Finger puppet, Bookworm reading intervention training and routine EDI care..
- Who it may be relevant to
- Registry conditions: Child Development, Infant Development, Infant, Premature, Diseases. Basic parameters: 1 Week — 17 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
Overview
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
- 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.
Primary outcome measures
- ASQ-3 scores [Time frame: 12 months corrected age]
Secondary outcome measures (12)
- ASQ-3 scores [Time frame: 24 months corrected age]
- ASQ scores below -2SD [Time frame: 12 months corrected age]
- ASQ scores below -2SD [Time frame: 24 months corrected age]
- ASQ scores below -1SD [Time frame: 12 months corrected age]
- ASQ scores below -1SD [Time frame: 24 months corrected age]
- ASQ-SE2 scores [Time frame: 12 months corrected age]
- ASQ-SE2 scores [Time frame: 24 months corrected age]
- Severe neurodevelopmental impairment [Time frame: 24 months corrected age]
- Moderate or severe neurodevelopmental impairment [Time frame: 24 months corrected age]
- Cognitive Composite Score on BSID-IV [Time frame: 24 months corrected age]
- Language Composite Score on BSID-IV [Time frame: 24 months corrected age]
- Motor Composite Score on BSID-IV [Time frame: 24 months corrected age]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06335524 · IRB-300012718 · UAB