NCT07511075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

March 16, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

shared readinginfant developmentrelational healthinterventionalneonatal intensive care uniteducational intervention

Outcome Measures

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 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

    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

Study Arms (2)

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.

Other: Shared reading program

Interventions

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.

ROR (Reach Out and Read) Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

March 16, 2026

First Posted

April 6, 2026

Study Start

October 18, 2021

Primary Completion

June 5, 2023

Study Completion

June 5, 2023

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations