Newborn Health Information Study

December 11, 2009 updated by: University of Rochester

Innovative Delivery of Newborn Anticipatory Guidance: The Incorporation of Media-Based Learning Into the Primary Care Office.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge of Infant Development
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

The Commonwealth Fund
Academic Pediatric Association

Investigators

  • Principal Investigator: Jill S Halterman, MD, MPH, University of Rochester
  • Principal Investigator: Heather A Paradis, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 14, 2009

Last Update Submitted That Met QC Criteria

December 11, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • RSRB00024779

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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