Houston, Texas 77030


Purpose:

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 systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.


Study summary:

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, & depression assessed in the home by a masked nurse at 8 wks. 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).


Criteria:

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


NCT ID:

NCT01217658


Primary Contact:

Christopher S Greeley, MD
Phone: 713-500-6643
Email: Christopher.S.Greeley@uth.tmc.edu


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Christopher S Greeley, MD
Phone: 713-500-6643
Email: Christopher.S.Greeley@uth.tmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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