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Sponsored by: |
Harborview Injury Prevention and Research Center |
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Information provided by: | Harborview Injury Prevention and Research Center |
ClinicalTrials.gov Identifier: | NCT00105963 |
This research project seeks to implement an early intervention program that can be effective in the prevention of Shaken Baby Syndrome (SBS) and infant abuse. Our hypothesis is that the Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through changes in knowledge, attitudes and behaviors about early infant crying, especially inconsolable crying. In this 3-year project, we will implement and evaluate an intervention program in selected prenatal classes, hospitals, and primary care pediatric practices.
In this randomized, controlled trial, we will enroll a total of 3000 women/families who are about to give birth or have just given birth to a healthy infant. At each of the three sites (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects. Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp cloth) about infant crying. The other half, the control group, will receive comparable materials on infant safety. All subjects will be asked to complete a brief questionnaire at the time of enrollment (pre test), review the materials they receive, complete the Baby’s Day Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire (post test) when the infant is 8 weeks of age.
Condition | Intervention |
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Child Abuse Shaken Baby Syndrome |
Behavioral: Education about infant crying |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse |
Estimated Enrollment: | 3000 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | August 2006 |
The specific goals of the program are:
Ages Eligible for Study: | up to 4 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
Harborview Injruy Prevention and Research Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Frederick P Rivara, MD 206-744-9449 fpr@u.washington.edu | |
Principal Investigator: Frederick P Rivara, MD | |
Sub-Investigator: James taylor, MD | |
Sub-Investigator: Liliana Lengua, PhD | |
Sub-Investigator: Ron Barr, MD | |
Sub-Investigator: Marilyn Sandberg, BA |
Study ID Numbers: | HIPRCSBS-01 |
Study First Received: | March 18, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00105963 History of Changes |
Health Authority: | United States: Institutional Review Board |
abuse |
Craniocerebral Trauma Wounds and Injuries Disorders of Environmental Origin |
Trauma, Nervous System Brain Injuries Shaken Baby Syndrome |
Craniocerebral Trauma Pathologic Processes Disease Syndrome Nervous System Diseases |
Wounds and Injuries Disorders of Environmental Origin Trauma, Nervous System Brain Injuries Shaken Baby Syndrome |