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CompletedNCT07511075Updated Apr 13, 2026

Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit

An interventional study of Shared reading program in Neonates or Premature Babies, Parent and Reading, sponsored by Catherine Caruso. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Catherine Caruso · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Oct 2021, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Non-randomized
Sex
All
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Study summary

This is a pre/post quasi-interventional study with two arms. First, a baseline cohort of parent-infant dyads admitted to the Neonatal Intensive Care Unit (NICU) were enrolled and surveyed at three timepoints (admission, discharge, and one-month post-discharge) to characterize baseline habits, attitudes, and barriers toward shared reading in the NICU in the absence of a shared reading program. Reach Out and Read (ROR) in the NICU, a shared reading program modified from the national ROR outpatient program to the NICU setting was then implemented. Following program implementation, a subsequent cohort of parent-infant dyads admitted to the NICU were enrolled (the "ROR" cohort) and surveyed at the same three timepoints. Feasibility, acceptability, and preliminary efficacy of ROR NICU to promote shared reading in the NICU were evaluated.

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Conditions studied

  • Neonates or Premature Babies
  • Parent
  • Reading
  • NICU Infants

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Keywords

  • shared reading
  • infant development
  • relational health
  • interventional
  • neonatal intensive care unit
  • educational intervention
03

In context

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 101 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

This is the only study on the registry with Catherine Caruso as lead sponsor.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Parent-infant dyads were recruited with the following criteria:

Inclusion criteria

Inclusion Criteria:

  • New neonatal admission to the NICU at less than or equal to 14 days old
  • Estimated length of stay 2 weeks or longer
  • English or Spanish speaking

Exclusion criteria

Exclusion Criteria:

  • Nonviable neonates or those with uncertain viability
  • Families with discontinuous social situations or parent/infant separation
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • No intervention
    Baseline, Pre-ROR (before Reach Out and Read) Cohort

    Baseline cohort of parent-infant dyads not exposed to the shared reading program Reach Out and Read in the NICU

  • Experimental
    ROR (Reach Out and Read) Cohort

    Parent-infant dyads in this group received children's books paired with anticipatory guidance on shared reading every two weeks during the infant's NICU stay.

    Other: Shared reading program

Interventions

  • OtherShared reading program

    Reach Out and Read in the NICU (ROR NICU) was implemented. All infants admitted to the NICU receive a book paired with education/anticipatory guidance on shared reading every two weeks during their NICU admission.

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What researchers measure

Primary outcomes

  1. Rate of regular reading

    Parent-reported frequency of shared reading (days/week) in the last week with "regular reading" defined as at least 3 times per week.

    Time frame: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2

Secondary outcomes

  1. Proportion of eligible infants who received the intervention

    This is a program fidelity measure assessing how many infants admitted to and discharged from the NICU received the intervention (defined as receiving a book paired with education about shared reading)

    Time frame: After infant discharge, average of 6 weeks from baseline.

  2. Program acceptability

    Survey questions exploring parent experience of the program and an "Acceptability of Intervention Measure" 4-item scaled score (likert scale 1-5) from Weiner et al 2017.

    Time frame: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2

  3. Frequency of intervention per patient (fidelity to the model)

    The frequency and timing of when each ROR cohort infant received a book during admission was tracked

    Time frame: After infant discharge, average of 6 weeks from baseline

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Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07511075
Lead sponsor
Catherine Caruso
Collaborators
Academic Pediatric Association
Responsible party
Catherine Caruso (Assistant Professor of Pediatrics, Oregon Health and Science University) — Sponsor-investigator
First posted
Apr 6, 2026
Start date
Oct 18, 2021
Primary completion
Jun 5, 2023
Completion
Jun 5, 2023
Last update
Apr 13, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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