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Infant Colic | Measuring and Reducing Excessive Infant Crying

Infant Colic research study

What is the primary objective of this study?

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 is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infant Colic

Postpartum Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:The Happiest Baby on The BlockThose receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

Behavioral:AAP Infant Colic counselingThose receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

The Happiest Baby on The BlockThose receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

AAP EducationThose receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).

Study Status

Completed

Start Date: January 2011

Completed Date: September 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Mean night-time crying

Secondary Outcome: Maternal Depression, Anxiety and Somatization

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: The University of Texas Health Science Center, Houston

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT01217658

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