Measuring and Reducing Excessive Infant Crying

Not Applicable

Completed

• Conditions: Postpartum Depression; Infant Colic

• Registration Number: NCT01217658
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2011-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean sleep duration	2 weeks after enrollment. Appproximately 6-8 weeks of life.	objectively measuring infant sleep duration
Mean night-time crying	2 weeks after enrollment. Appproximately 6-8 weeks of life.	Objectively recording night-time duration of excessive crying

Secondary Outcome Measures

Name	Time	Method
Maternal Depression, Anxiety and Somatization	At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.	Using the BSI-18 at study enrollment and conclusion.
Salivary Biomarkers	At Study Entry and at 2 weeks after enrollment	We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States