- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07511075
Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit
April 6, 2026 updated by: Catherine Caruso
Developmental Promotion in the Neonatal Intensive Care Unit; A New Shared Reading Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Parent-infant dyads were recruited with the following 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:
- Nonviable neonates or those with uncertain viability
- Families with discontinuous social situations or parent/infant separation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of regular reading
Time Frame: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2
|
Parent-reported frequency of shared reading (days/week) in the last week with "regular reading" defined as at least 3 times per week.
|
Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of eligible infants who received the intervention
Time Frame: After infant discharge, average of 6 weeks from baseline.
|
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)
|
After infant discharge, average of 6 weeks from baseline.
|
|
Program acceptability
Time Frame: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2
|
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 point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2
|
|
Frequency of intervention per patient (fidelity to the model)
Time Frame: After infant discharge, average of 6 weeks from baseline
|
The frequency and timing of when each ROR cohort infant received a book during admission was tracked
|
After infant discharge, average of 6 weeks from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2021
Primary Completion (Actual)
June 5, 2023
Study Completion (Actual)
June 5, 2023
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
March 31, 2026
First Posted (Actual)
April 6, 2026
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00022938
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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