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N/A N=51 Randomized Double-blind Treatment

An Intervention to Decrease Infant Crying

Colic

Enrolled (actual)
51
Serious AEs
Results posted
Nov 2008
Primary outcome: Primary: Hours Per Day of Fuss/Cry — 2.20; 1.48 hours per day

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Happiest Baby videotape (Behavioral); control videotape (Behavioral)
Age
Pediatric
Sex
All
Sponsor
Riverside Methodist Hospital
Primary completion
Feb 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Hours Per Day of Fuss/Cry
2.20; 1.48
PRIMARY
Hours Per Day of Sleep
13.87; 14.1
SECONDARY
Parenting Stress Index
225.3; 188.9

Summary

This is a study looking at the Happiest Baby on the Block technique. The investigators hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers given a 30 minute videotape on general newborn care. The investigators also hypothesized that mothers given the Happiest Baby on the Block videotape would have lower levels of stress.

Eligibility Criteria

Inclusion Criteria

Mothers of singleton newborns

  • 37 to 41 week gestation
  • healthy (no ICU admission)

Exclusion Criteria

  • not able to view videotape at home
  • not able to speak English
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00796523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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