Prevention of Shaken Baby Syndrome
Status unconfirmed · Not applicable
Conditions studied: Child Abuse, Shaken Baby Syndrome
In brief
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.
Key facts
- Study ID
- NCT00105963
- Run by
- Harborview Injury Prevention and Research Center
- People needed
- 3000
- Starts
- 2005-01-01
- Expected to finish
- 2006-08-01
- Last updated by the study team
- 2005-06-24
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects must be new parents or parents to be who are either: 1) attending participating prenatal classes; 2) delivering a baby at the participating hospital; or 3) visiting a PSPRN (Puget Sound Pediatric Research Network) pediatrician for infant care.
- Only parents of infants born at > 34 weeks gestation are eligible.
You may not qualify if…
- Parents of infants who have serious medical conditions.
- Parents who don't speak and read English.
- Parents of infants born at < 34 weeks gestation.
Where it is running
- Harborview Injruy Prevention and Research Center — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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