Measuring and Reducing Excessive Infant Crying (UTHealth THB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Christopher Greeley, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01217658
First received: October 6, 2010
Last updated: November 19, 2013
Last verified: November 2013

October 6, 2010
November 19, 2013
January 2011
December 2015   (final data collection date for primary outcome measure)
  • Mean night-time crying [ Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life. ] [ Designated as safety issue: No ]
    Objectively recording night-time duration of excessive crying
  • Mean sleep duration [ Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life. ] [ Designated as safety issue: No ]
    objectively measuring infant sleep duration
  • Mean night-time crying [ Time Frame: 6pm to 6am, each evening ] [ Designated as safety issue: No ]
    Objectively recording night-time duration of excessive crying
  • Mean sleep duration [ Time Frame: 6pm to 6am, each evening ] [ Designated as safety issue: No ]
    objectively measuring infant sleep duration
Complete list of historical versions of study NCT01217658 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    Using the BSI-18 at study enrollment and conclusion.
  • Salivary Biomarkers [ Time Frame: At Study Entry and at 2 weeks after enrollment ] [ Designated as safety issue: No ]
    We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
Maternal Depression, Anxiety and Somatization [ Time Frame: At study entry and conculsion (4 week interval) ] [ Designated as safety issue: No ]
Using the BSI-18 at study enrollment and conclusion.
Not Provided
Not Provided
 
Measuring and Reducing Excessive Infant Crying
Measuring and Reducing Excessive Infant Crying: A Randomized Trial

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infant Colic
  • Postpartum Depression
  • 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.
  • Experimental: 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".
    Intervention: Behavioral: The Happiest Baby on The Block
  • Active Comparator: AAP Education
    Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic.
    Intervention: Behavioral: AAP Infant Colic counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
up to 5 Weeks
No
Contact: Christopher S Greeley, MD 713-500-6643 Christopher.S.Greeley@uth.tmc.edu
United States
 
NCT01217658
HSC-MS-10-0392, K23HD065872
No
Christopher Greeley, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
The University of Texas Health Science Center, Houston
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP