CompletedNot Applicable

Measuring and Reducing Excessive Infant Crying

United States28 participantsStarted 2011-01

Plain-language 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 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.

Who can participate

Age range3 Weeks – 5 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean night-time crying

Timeframe: 2 weeks after enrollment. Appproximately 6-8 weeks of life.

Mean sleep duration

Timeframe: 2 weeks after enrollment. Appproximately 6-8 weeks of life.

Trial details

NCT IDNCT01217658

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Infant Colic trials