Skip to main content
OpenTrials
Completed

NCT Number: NCT01217658

Measuring and Reducing Excessive Infant Crying

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Happiest Baby on The Block

Behavioral

Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

AAP Infant Colic counseling

Behavioral

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

Primary outcomes

  1. Mean night-time crying

    Time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.

    Objectively recording night-time duration of excessive crying

  2. Mean sleep duration

    Time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.

    objectively measuring infant sleep duration

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Measuring and Reducing Excessive Infant Crying: A Randomized Trial

Acronym: UTHealth THB

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2010
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.