Neonates or Premature BabiesNCT07511075
Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit
A study testing Shared reading program in people with Neonates or Premature Babies and Parent, run by Catherine Caruso at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonates or Premature Babies, Parent, Reading
- What is being tested?
- Shared reading program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nonviable neonates or those with uncertain viability
- Families with discontinuous social situations or parent/infant separation
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
- Conditions
- Neonates or Premature Babies, Parent, Reading, NICU Infants
- Being tested
- Shared reading program
- Keywords
- shared reading, infant development, relational health, interventional, neonatal intensive care unit, educational intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared reading programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline, Pre-ROR (before Reach Out and Read) Cohort | No intervention | Baseline cohort of parent-infant dyads not exposed to the shared reading program Reach Out and Read in the NICU |
| ROR (Reach Out and Read) Cohort | Experimental | 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. Receives: Other: Shared reading program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2
Secondary outcomes (3)
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)
Measured: After infant discharge, average of 6 weeks from baseline.
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.
Measured: 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)
The frequency and timing of when each ROR cohort infant received a book during admission was tracked
Measured: After infant discharge, average of 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start18 Oct 2021
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates or Premature BabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A baseline cohort not exposed to a shared reading program was recruited and surveyed at three timepoints. After implementing a shared reading program, a second cohort (exposed to the shared reading program) was recruited and surveyed at the same three timepoints. Cohorts were then compared.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Caruso
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Pediatric Association
- Responsible party
- Sponsor-investigator, Catherine Caruso, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511075
- Sponsor's protocol ID
- 00022938
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Promotion in the Neonatal Intensive Care Unit; A New Shared Reading Program
- ClinicalTrials.gov ID
- NCT07511075
- Acronym / sponsor ID
- 00022938
- Conditions
- Neonates or Premature Babies, Parent, Reading, NICU Infants
- Keywords
- shared reading, infant development, relational health, interventional, neonatal intensive care unit, educational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Catherine CarusoUniversity, hospital or other
- Collaborators
- Academic Pediatric Association
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A baseline cohort not exposed to a shared reading program was recruited and surveyed at three timepoints. After implementing a shared reading program, a second cohort (exposed to the shared reading program) was recruited and surveyed at the same three timepoints. Cohorts were then compared.
| Arm | Type | Receives |
|---|---|---|
| Baseline, Pre-ROR (before Reach Out and Read) Cohort | No intervention | –Baseline cohort of parent-infant dyads not exposed to the shared reading program Reach Out and Read in the NICU |
| ROR (Reach Out and Read) Cohort | Experimental | Other: Shared reading programParent-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Nonviable neonates or those with uncertain viability
- Families with discontinuous social situations or parent/infant separation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared reading programReach 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. | Other | ROR (Reach Out and Read) Cohort |
Primary outcome
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.
3 secondary outcomes
Proportion of eligible infants who received the intervention
Time frame: 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
Frequency of intervention per patient (fidelity to the model)
Time frame: After infant discharge, average of 6 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared reading program in people with Neonates or Premature Babies and Parent, run by Catherine Caruso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.