Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2011-01-31
2015-09-30
Brief Summary
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Detailed Description
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Methods: Term singleton infants with EIC (\> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant \& maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
AAP Education
Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).
AAP Infant Colic counseling
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Interventions
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The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
AAP Infant Colic counseling
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Eligibility Criteria
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Inclusion Criteria
* 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
3 Weeks
5 Weeks
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Christopher Greeley
Associate Professor - Pediatrics
Locations
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University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Related Links
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American Academy of Pediatrics Infant Colic Website
Other Identifiers
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HSC-MS-10-0392
Identifier Type: -
Identifier Source: org_study_id