An Intervention to Decrease Infant Crying

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Care Provider, 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.
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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
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)
Gender; [Units: Mothers]
Female	27	24	51
Male	0	0	0
Region of Enrollment; [Units: Participants]
United States	27	24	51

  Outcome Measures

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

Parenting Stress Index [ Time Frame: week 6 ]

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  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
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  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
First Submitted:	October 16, 2008
First Posted:	November 24, 2008
Results First Submitted:	October 16, 2008
Results First Posted:	November 24, 2008
Last Update Posted:	November 24, 2008