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NCT Number: NCT06335524

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

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.

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Key information

Conditions

Child Development Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant Development Infant, Newborn, Diseases Infant, Premature, Diseases

Age range

1 week–17 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. ASQ-3 scores

    Time frame: 12 months corrected age

    Ages and Stages Questionnaires 3rd Edition

Secondary outcomes

  1. ASQ-3 scores

    Time frame: 24 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  2. ASQ scores below -2SD

    Time frame: 12 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  3. ASQ scores below -2SD

    Time frame: 24 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  4. ASQ scores below -1SD

    Time frame: 12 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  5. ASQ scores below -1SD

    Time frame: 24 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  6. ASQ-SE2 scores

    Time frame: 12 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  7. ASQ-SE2 scores

    Time frame: 24 months corrected age

    Ages and Stages Questionnaires 3rd Edition

  8. Severe neurodevelopmental impairment

    Time frame: 24 months corrected age

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

  9. Moderate or severe neurodevelopmental impairment

    Time frame: 24 months corrected age

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

  10. Cognitive Composite Score on BSID-IV

    Time frame: 24 months corrected age

    Bayley's Scales of Infant Development IV cognitive composite score

  11. Language Composite Score on BSID-IV

    Time frame: 24 months corrected age

    Bayley's Scales of Infant Development IV language composite score

  12. Motor Composite Score on BSID-IV

    Time frame: 24 months corrected age

    Bayley's Scales of Infant Development IV motor composite score

  13. Edinburgh Postnatal Depression Scale

    Time frame: 6 months

    Maternal scores on Edinburgh Postnatal Depression Scale

  14. MCHAT score

    Time frame: 24 months corrected age

    Modified Checklist for Autism in Toddlers

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly M Armstead

CONTACT

[email protected]

2059340095

Tamaryn H Garcia

CONTACT

[email protected]

2059344680

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 28, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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