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An Intervention to Decrease Infant Crying

This study has been completed.
Sponsor:
Collaborator:
Prevent Child Abuse America
Information provided by:
Riverside Methodist Hospital
ClinicalTrials.gov Identifier:
NCT00796523
First received: October 16, 2008
Last updated: November 21, 2008
Last verified: November 2008
History of Changes
Results First Received: October 16, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Colic
Interventions: Behavioral: Happiest Baby videotape
Behavioral: control videotape

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Mothers of healthy singleton newborn infants with a gestational age of 37-41 weeks admitted to the normal newborn nursery of a large community hospital were given a flier inviting them to participate by contacting the research assistant by phone.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1408 Fliers were distributed and 51 mothers contacted the research assistant for enrollment in the study.

Reporting Groups
  Description
Happiest Baby Videotape videotape describing the Happiest Baby on the Block technique
Control Videotape videotape with normal newborn instruction

Participant Flow:   Overall Study
    Happiest Baby Videotape     Control Videotape  
STARTED     27     24  
COMPLETED     18     17  
NOT COMPLETED     9     7  
Lost to Follow-up                 9                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Happiest Baby Videotape videotape describing the Happiest Baby on the Block technique
Control Videotape videotape with normal newborn instruction
Total Total of all reporting groups

Baseline Measures
    Happiest Baby Videotape     Control Videotape     Total  
Number of Participants  
[units: participants]
 		  27     24     51  
Age [1]
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     27     24     51  
>=65 years     0     0     0  
Age [1]
[units: years]
Mean (Standard Deviation) 		  29  (6)     30  (4)     29  (5)  
Age [2]
[units: days]
Mean (Standard Deviation) 		  3  (1)     3  (1)     3  (1)  
Age, Customized [2]
[units: participants]
 		     
<=5 days     27     24     51  
>5 days     0     0     0  
Gender  
[units: mothers]
 		     
Female     27     24     51  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     27     24     51  
[1] (mothers)
[2] (babies)



  Outcome Measures
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1.  Primary:   Hours Per Day of Fuss/Cry   [ Time Frame: week 8 ]
  Show Outcome Measure 1

2.  Primary:   Hours Per Day of Sleep   [ Time Frame: week 8 ]
  Show Outcome Measure 2

3.  Secondary:   Parenting Stress Index   [ Time Frame: week 6 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jonna M. McRury, M.D.
Organization: University of Toledo
phone: 419-389-1118
e-mail: jmcrury@aol.com



Responsible Party: Jonna M. McRury, M.D., University of Toledo
ClinicalTrials.gov Identifier: NCT00796523     History of Changes
Other Study ID Numbers: 941
Study First Received: October 16, 2008
Results First Received: October 16, 2008
Last Updated: November 21, 2008
Health Authority: United States: Institutional Review Board