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Chiropractic Manual Therapy in Infantile Colic

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ClinicalTrials.gov Identifier: NCT01513304
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):
Professor Jennifer Bolton, Anglo-European College of Chiropractic

Tracking Information
First Submitted Date  ICMJE January 17, 2012
First Posted Date  ICMJE January 20, 2012
Last Update Posted Date January 20, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January¬†19,¬†2012)
Daily crying diary
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chiropractic Manual Therapy in Infantile Colic
Official Title  ICMJE Not Provided
Brief Summary Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Infantile Colic
Intervention  ICMJE Procedure: Manual therapy
Study Arms  ICMJE Experimental: Chiropractic manual therapy
Intervention: Procedure: Manual therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Excessive crying,
  • infant less than 8weeks of age,
  • born at gestational age 37 weeks or later, otherwise healthy

Exclusion Criteria:

  • Not accepted for chiropractic care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 8 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01513304
Other Study ID Numbers  ICMJE AECCRCT1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Jennifer Bolton, Anglo-European College of Chiropractic
Study Sponsor  ICMJE Professor Jennifer Bolton
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anglo-European College of Chiropractic
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP