Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

Child Development Clinical Trial

— IMPACT  

Official title:

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335524
• Other study ID #: IRB-300012718
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: August 2028

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Tamaryn H Garcia
• Phone: 2059344680
• Email: thgarcia[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: August 2028
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 17 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Child Development
• Infant Development
• Infant, Premature, Diseases

Intervention

Behavioral:
• Finger puppet
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.
Routine EDI care including Bookworm training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASQ-3 scores	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
Secondary	ASQ-3 scores	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
Secondary	ASQ scores below -2SD	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
Secondary	ASQ scores below -2SD	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
Secondary	ASQ scores below -1SD	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
Secondary	ASQ scores below -1SD	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
Secondary	ASQ-SE2 scores	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
Secondary	ASQ-SE2 scores	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
Secondary	Severe neurodevelopmental impairment	Composite outcome based on BSID scores, GMFCS, Vision, Hearing	24 months corrected age
Secondary	Moderate or severe neurodevelopmental impairment	Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing	24 months corrected age
Secondary	Cognitive Composite Score on BSID-IV	Bayley's Scales of Infant Development IV cognitive composite score	24 months corrected age
Secondary	Language Composite Score on BSID-IV	Bayley's Scales of Infant Development IV language composite score	24 months corrected age
Secondary	Motor Composite Score on BSID-IV	Bayley's Scales of Infant Development IV motor composite score	24 months corrected age
Secondary	Edinburgh Postnatal Depression Scale	Maternal scores on Edinburgh Postnatal Depression Scale	6 months
Secondary	MCHAT score	Modified Checklist for Autism in Toddlers	24 months corrected age