Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

An Intervention to Decrease Infant Crying

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

  Participant Flow
  Hide Participant Flow

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
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 
Lost to Follow-up                9                7 

  Baseline Characteristics
  Hide Baseline Characteristics

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
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 
Overall Participants Analyzed 
[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 
[1] (mothers)
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 29  (6)   30  (4)   29  (5) 
[1] (mothers)
Age [1] 
[Units: Days]
Mean (Standard Deviation)
 3  (1)   3  (1)   3  (1) 
[1] (babies)
Age, Customized [1] 
[Units: Participants]
<=5 days   27   24   51 
>5 days   0   0   0 
[1] (babies)
[Units: Mothers]
Female   27   24   51 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   27   24   51 

  Outcome Measures
  Show All Outcome Measures

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

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

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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

Responsible Party: Jonna M. McRury, M.D., University of Toledo 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