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RecruitingNCT06335524IMPACTUpdated Dec 29, 2025

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

An interventional study of Finger puppet and Bookworm reading intervention training and routine EDI care. in Child Development, Infant Development and Infant, Premature, Diseases, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 1 Week to 17 Weeks. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
1 Week to 17 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Child Development
  • Infant Development
  • Infant, Premature, Diseases
03

In context

Infant, Premature, Diseases

100 studies on the registry are indexed under Infant, Premature, Diseases; 16 are open to participants now.

This study's planned enrollment of 188 is above the median of 62 across 64 interventional studies indexed under Infant, Premature, Diseases.

Browse Infant, Premature, Diseases studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week to 17 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
188 participants (estimated)

Study arms

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

    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.

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

  • Active comparator
    Routine EDI care including Bookworm training

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

    Behavioral: Bookworm reading intervention training and routine EDI care.

Interventions

  • BehavioralFinger puppet

    The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.

  • BehavioralBookworm reading intervention training and routine EDI care.

    Routine EDI care including Bookworm training.

06

What researchers measure

Primary outcomes

  1. ASQ-3 scores

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 12 months corrected age

Secondary outcomes

  1. ASQ-3 scores

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 24 months corrected age

  2. ASQ scores below -2SD

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 12 months corrected age

  3. ASQ scores below -2SD

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 24 months corrected age

  4. ASQ scores below -1SD

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 12 months corrected age

  5. ASQ scores below -1SD

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 24 months corrected age

  6. ASQ-SE2 scores

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 12 months corrected age

  7. ASQ-SE2 scores

    Ages and Stages Questionnaires 3rd Edition

    Time frame: 24 months corrected age

  8. Severe neurodevelopmental impairment

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

    Time frame: 24 months corrected age

  9. Moderate or severe neurodevelopmental impairment

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

    Time frame: 24 months corrected age

  10. Cognitive Composite Score on BSID-IV

    Bayley's Scales of Infant Development IV cognitive composite score

    Time frame: 24 months corrected age

  11. Language Composite Score on BSID-IV

    Bayley's Scales of Infant Development IV language composite score

    Time frame: 24 months corrected age

  12. Motor Composite Score on BSID-IV

    Bayley's Scales of Infant Development IV motor composite score

    Time frame: 24 months corrected age

  13. Edinburgh Postnatal Depression Scale

    Maternal scores on Edinburgh Postnatal Depression Scale

    Time frame: 6 months

  14. MCHAT score

    Modified Checklist for Autism in Toddlers

    Time frame: 24 months corrected age

07

Study locations

1 of 1 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06335524
Lead sponsor
University of Alabama at Birmingham
Responsible party
Colm Travers (Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Mar 28, 2024
Start date
Nov 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Dec 29, 2025

Study contacts

Tamaryn H Garcia
Contact
thgarcia@uabmc.edu
2059344680
Kimberly M Armstead
Contact
karmstead@uabmc.edu
2059340095
Colm P Travers
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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