Clinical trial NCT01217658: Measuring and Reducing Excessive Infant Crying
Official title: Measuring and Reducing Excessive Infant Crying: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Colic
Postpartum Depression
Keywords: Randomized Trial
Infant Colic
Abusive Head Trauma
Shaken Baby Syndrome
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-10-08
Enrollment: 28
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Eligibility 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

Primary outcomes:
measure: Mean night-time crying
timeFrame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
measure: Mean sleep duration
timeFrame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Secondary outcomes:
measure: Maternal Depression, Anxiety and Somatization
timeFrame: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
measure: Salivary Biomarkers
timeFrame: At Study Entry and at 2 weeks after enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References: