Status:
COMPLETED
Measuring and Reducing Excessive Infant Crying
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant Colic
Postpartum Depression
Eligibility:
All Genders
3-5 years
Phase:
NA
Brief Summary
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will...
Detailed Description
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress,...
Eligibility Criteria
Inclusion
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
Exclusion
- cannot have a condition which would reasonably impact alertness or behavior
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01217658
Start Date
January 1 2011
End Date
September 1 2015
Last Update
December 8 2015
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030