Houston, Texas 77030


Purpose:

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.


Study 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).


Criteria:

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 is Available At:


Original ID:

HSC-MS-10-0392


NCT ID:

NCT01217658


Secondary ID:

K23HD065872


Study Acronym:

UTHealth THB


Brief Title:

Measuring and Reducing Excessive Infant Crying


Official Title:

Measuring and Reducing Excessive Infant Crying: A Randomized Trial


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

5 Weeks


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas Health Science Center, Houston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

180


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Christopher S Greeley, MD
713-500-6643
Christopher.S.Greeley@uth.tmc.edu

Study Dates

Start Date:January 2011
Completion Date:December 2015
Completion Type:Anticipated
Primary Completion Date:December 2015
Primary Completion Type:Anticipated
Verification Date:December 2014
Last Changed Date:December 2, 2014
First Received Date:October 6, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Salivary Biomarkers
Time Frame:At Study Entry and at 2 weeks after enrollment
Safety Issues:False
Description:We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
Outcome Type:Secondary Outcome
Measure:Maternal Depression, Anxiety and Somatization
Time Frame:At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks
Safety Issues:False
Description:Using the BSI-18 at study enrollment and conclusion.
Outcome Type:Primary Outcome
Measure:Mean sleep duration
Time Frame:2 weeks after enrollment. Appproximately 6-8 weeks of life.
Safety Issues:False
Description:objectively measuring infant sleep duration
Outcome Type:Primary Outcome
Measure:Mean night-time crying
Time Frame:2 weeks after enrollment. Appproximately 6-8 weeks of life.
Safety Issues:False
Description:Objectively recording night-time duration of excessive crying

Study Interventions

Intervention Type:Behavioral
Name:AAP Infant Colic counseling
Description:Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Arm Name:AAP Education
Intervention Type:Behavioral
Name:The Happiest Baby on The Block
Description:Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
Arm Name:The Happiest Baby on The Block

Study Arms

Study Arm Type:Active Comparator
Arm Name:AAP Education
Description:Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic.
Study Arm Type:Experimental
Arm Name:The Happiest Baby on The Block
Description:Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Health Science Center, Houston
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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