NCT01217658

Measuring and Reducing Excessive Infant Crying

Measuring and Reducing Excessive Infant Crying: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 3 Weeks – 5 Weeks
• Healthy volunteers: Not accepted

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).

Conditions

• Infant Colic
• Postpartum Depression

Interventions

Type	Name	Description
BEHAVIORAL	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".
BEHAVIORAL	AAP Infant Colic counseling	Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2010-10-08
• Last updated: 2015-12-08

Locations

1 site across 1 country: United States