Measuring and Reducing Excessive Infant Crying

Postpartum Depression Clinical Trial

— UTHealth THB  

Official title:

Measuring and Reducing Excessive Infant Crying: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217658
• Other study ID #: HSC-MS-10-0392
• Secondary ID: K23HD065872
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: December 4, 2015
• Start date: January 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Depression, Postpartum
• Infant Colic
• Postpartum Depression

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean night-time crying	Objectively recording night-time duration of excessive crying	2 weeks after enrollment. Appproximately 6-8 weeks of life.	No
Primary	Mean sleep duration	objectively measuring infant sleep duration	2 weeks after enrollment. Appproximately 6-8 weeks of life.	No
Secondary	Maternal Depression, Anxiety and Somatization	Using the BSI-18 at study enrollment and conclusion.	At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.	No
Secondary	Salivary Biomarkers	We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)	At Study Entry and at 2 weeks after enrollment	No

External Links

•   American Academy of Pediatrics Infant Colic Website