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Newborn Health Information Study
This study is currently recruiting participants.
Verified by University of Rochester, January 2009
First Received: January 8, 2009   No Changes Posted
Sponsors and Collaborators: University of Rochester
The Commonwealth Fund
Academic Pediatric Association
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00820677
  Purpose

This is a randomized, controlled trial to test the use of an educational video during the newborn well-child visit. Parents who watch the video during their medical visit will be compared to those parents who receive traditional paper handouts. Measures obtained at baseline and 2-week follow-up include knowledge of infant development, self-efficacy with infant care, and problem-solving skills.


Condition Intervention
Infant, Newborn
Behavioral: DVD/Video

U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Innovative Delivery of Newborn Anticipatory Guidance: The Incorporation of Media-Based Learning Into the Primary Care Office.

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Knowledge of Infant Development [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DVD/Video: Experimental
Parents of newborns in the experimental group attending their first baby visit will be shown a video about newborn care.
Behavioral: DVD/Video
One DVD or Video will be watched by all parents of newborns enrolled into the experimental group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Baby's first visit to the pediatric office

Exclusion Criteria:

  • Baby > 1 month old
  • Parent/Caregiver < 18yrs old
  • Inability to understand English
  • No access to a working telephone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820677

Contacts
Contact: Heather Paradis, MD 585-275-1827 heather_paradis@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Heather Paradis, MD     585-275-1827     heather_paradis@urmc.rochester.edu    
Sponsors and Collaborators
University of Rochester
The Commonwealth Fund
Academic Pediatric Association
  More Information

No publications provided

Responsible Party: University of Rochester ( Heather Paradis, MD )
Study ID Numbers: RSRB00024779
Study First Received: January 8, 2009
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00820677     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 06, 2009