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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 May 2013 |
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Main ID: |
NCT01217658 |
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Date of registration:
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06/10/2010 |
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Primary sponsor: |
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Public title:
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Measuring and Reducing Excessive Infant Crying
UTHealth THB |
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Scientific title:
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Measuring and Reducing Excessive Infant Crying: A Randomized Trial |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01217658 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher S Greeley, MD |
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Address:
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Telephone:
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713-500-6643 |
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Email:
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Christopher.S.Greeley@uth.tmc.edu |
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Affiliation:
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Name:
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Christopher S Greeley, MD |
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Address:
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Telephone:
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713-500-6643 |
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Email:
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Christopher.S.Greeley@uth.tmc.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- cannot have a condition which would reasonably impact alertness or behavior
Age minimum:
N/A
Age maximum:
5 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infant Colic
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Postpartum Depression
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Intervention(s)
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Behavioral: AAP Infant Colic counseling
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Behavioral: The Happiest Baby on The Block
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Primary Outcome(s)
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Mean night-time crying
[Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.]
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Mean sleep duration
[Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.]
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Secondary Outcome(s)
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Maternal Depression, Anxiety and Somatization
[Time Frame: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.]
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Salivary Biomarkers
[Time Frame: At Study Entry and at 2 weeks after enrollment]
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Secondary ID(s)
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HSC-MS-10-0392
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K23HD065872
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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