Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants (IMPACT)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Infant, Premature, Diseases; Child Development; Infant Development

Treatments: Behavioral: Bookworm reading intervention training and routine EDI care.; Behavioral: Finger puppet

Study type: Interventional

Funder types: Other

Identifiers

NCT06335524

IRB-300012718

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 1 to 17 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

Caregiver-implemented early developmental intervention (EDI) using finger puppets

Experimental group

Description:

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.

Treatment:

Behavioral: Finger puppet

Behavioral: Bookworm reading intervention training and routine EDI care.

Routine EDI care including Bookworm training

Active Comparator group

Description:

All study participants will receive Bookworm reading intervention training and routine EDI care.

Treatment:

Behavioral: Bookworm reading intervention training and routine EDI care.