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Newborn Health Information Study

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ClinicalTrials.gov Identifier: NCT00820677
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : December 14, 2009
Sponsor:
Collaborators:
The Commonwealth Fund
Academic Pediatric Association
Information provided by:
University of Rochester

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Infant, Newborn Behavioral: DVD/Video Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Innovative Delivery of Newborn Anticipatory Guidance: The Incorporation of Media-Based Learning Into the Primary Care Office.
Study Start Date : November 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: DVD/Video
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.


Outcome Measures
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Primary Outcome Measures :
  1. Knowledge of Infant Development [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820677


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
The Commonwealth Fund
Academic Pediatric Association
Investigators
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Principal Investigator: Heather A Paradis, MD University of Rochester
Principal Investigator: Jill S Halterman, MD, MPH University of Rochester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heather Paradis, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00820677    
Other Study ID Numbers: RSRB00024779
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: December 14, 2009
Last Verified: January 2009