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CompletedNCT00820677Updated Dec 14, 2009

Newborn Health Information Study

An interventional study of DVD/Video in Infant, Newborn, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-14.

Sponsored by University of Rochester · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infant, Newborn
03

In context

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Baby's first visit to the pediatric office

Exclusion criteria

Exclusion Criteria:

  • Baby > 1 month old
  • Parent/Caregiver \< 18yrs old
  • Inability to understand English
  • No access to a working telephone
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
137 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralDVD/Video

    One DVD or Video will be watched by all parents of newborns enrolled into the experimental group.

06

What researchers measure

Primary outcomes

  1. Knowledge of Infant Development

    Time frame: 2 weeks

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Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
08

References and documents

Publications

  • Paradis HA, Conn KM, Gewirtz JR, Halterman JS. Innovative delivery of newborn anticipatory guidance: a randomized, controlled trial incorporating media-based learning into primary care. Acad Pediatr. 2011 Jan-Feb;11(1):27-33. doi: 10.1016/j.acap.2010.12.005. PubMed 21272821 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00820677
Lead sponsor
University of Rochester
Collaborators
The Commonwealth Fund, Academic Pediatric Association
First posted
Jan 12, 2009
Start date
Nov 2008
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Dec 14, 2009

Study contacts

Heather A Paradis, MD
principal investigator · University of Rochester
Jill S Halterman, MD, MPH
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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