Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit (NCT07511075) | Clinical Trial Compass
CompletedNot Applicable
Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit
United States101 participantsStarted 2021-10-18
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of regular reading
Timeframe: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2