Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

ConditionsChild Development Infant Development Infant, Premature, Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-17

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.

Disqualifiers

a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.

Trial design

Design model

Parallel

Treatments tested in this trial

Finger puppet
Behavioral
The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
Bookworm reading intervention training and routine EDI care.
Behavioral
Routine EDI care including Bookworm training.

Treatment groups

188 Participants

are divided into 2 treatment groups

Group A: Caregiver-implemented early developmental intervention (EDI) using finger puppetsExperimental treatment 2 interventions

Group B: Routine EDI care including Bookworm trainingActive comparator 1 intervention