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Clinical Trials/NCT07511075
NCT07511075
Completed
Not Applicable

Developmental Promotion in the Neonatal Intensive Care Unit; A New Shared Reading Program

Catherine Caruso1 site in 1 country101 target enrollmentStarted: October 18, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Catherine Caruso
Enrollment
101
Locations
1
Primary Endpoint
Rate of regular reading

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Other
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Shared reading program (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Proportion of eligible infants who received the intervention(After infant discharge, average of 6 weeks from baseline.)
  • Program acceptability(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)(After infant discharge, average of 6 weeks from baseline)

Investigators

Sponsor
Catherine Caruso
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Catherine Caruso

Assistant Professor of Pediatrics

Oregon Health and Science University

Study Sites (1)

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