Clinical Trial: Measuring and Reducing Excessive Infant Crying

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Measuring and Reducing Excessive Infant Crying: A Randomized Trial

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 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).


Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome:

  • Mean night-time crying [ Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life. ]
    Objectively recording night-time duration of excessive crying
  • Mean sleep duration [ Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life. ]
    objectively measuring infant sleep duration


Original Primary Outcome:

  • Mean night-time crying [ Time Frame: 6pm to 6am, each evening ]
    Objectively recording night-time duration of excessive crying
  • Mean sleep duration [ Time Frame: 6pm to 6am, each evening ]
    objectively measuring infant sleep duration


Current Secondary Outcome:

  • Maternal Depression, Anxiety and Somatization [ Time Frame: 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 [ Time Frame: 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)


Original Secondary Outcome: Maternal Depression, Anxiety and Somatization [ Time Frame: At study entry and conculsion (4 week interval) ]

Using the BSI-18 at study enrollment and conclusion.


Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: October 6, 2010
Date Started: January 2011
Date Completion:
Last Updated: December 4, 2015
Last Verified: December 2015