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Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

Not Applicable
Recruiting
Conditions
Infant, Premature, Diseases
Child Development
Infant Development
Registration Number
NCT06335524
Lead Sponsor
University of Alabama at Birmingham
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
188
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
ASQ-3 scores12 months corrected age

Ages and Stages Questionnaires 3rd Edition

Secondary Outcome Measures
NameTimeMethod
Edinburgh Postnatal Depression Scale6 months

Maternal scores on Edinburgh Postnatal Depression Scale

ASQ scores below -2SD24 months corrected age

Ages and Stages Questionnaires 3rd Edition

ASQ-3 scores24 months corrected age

Ages and Stages Questionnaires 3rd Edition

Severe neurodevelopmental impairment24 months corrected age

Composite outcome based on BSID scores, GMFCS, Vision, Hearing

Language Composite Score on BSID-IV24 months corrected age

Bayley's Scales of Infant Development IV language composite score

ASQ scores below -1SD24 months corrected age

Ages and Stages Questionnaires 3rd Edition

ASQ-SE2 scores24 months corrected age

Ages and Stages Questionnaires 3rd Edition

Moderate or severe neurodevelopmental impairment24 months corrected age

Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing

Cognitive Composite Score on BSID-IV24 months corrected age

Bayley's Scales of Infant Development IV cognitive composite score

Motor Composite Score on BSID-IV24 months corrected age

Bayley's Scales of Infant Development IV motor composite score

MCHAT score24 months corrected age

Modified Checklist for Autism in Toddlers

Trial Locations

Locations (1)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Colm P Travers, MD
Contact
205-934-4680
ctravers@peds.uab.edu
Jillian Hamilton, PhD
Contact
2059344680
jchamilton@uabmc.edu
Waldemar A Carlo, MD
Sub Investigator

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