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Feeding Intervention for Infants With Crying

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ClinicalTrials.gov Identifier: NCT01017991
Recruitment Status : Terminated (The study has been terminated as a result of low enrollment.)
First Posted : November 23, 2009
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE November 20, 2009
First Posted Date  ICMJE November 23, 2009
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE December 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2009)
daily total crying time [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2009)
  • Formula intake [ Time Frame: 4 days ]
  • Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies [ Time Frame: 4 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feeding Intervention for Infants With Crying
Official Title  ICMJE Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".
Brief Summary The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Crying
Intervention  ICMJE
  • Other: Milk based infant formula with probiotic
    formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
  • Other: Milk based infant formula
    supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
Study Arms  ICMJE
  • Experimental: Infant formula with probiotic
    Infant formula with probiotic for 0 to 12 months of age
    Intervention: Other: Milk based infant formula with probiotic
  • Placebo Comparator: Standard infant formula
    Infant formula for 0 to 12 months of age
    Intervention: Other: Milk based infant formula
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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2012)
65
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2009)
138
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • full term infants greater than or equal to 37 wks gestation
  • 3 weeks to less than or equal to 4 months of age upon enrollment
  • experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
  • otherwise healthy as reported by parent/caregiver
  • is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
  • taking no more than one feeding of breast milk per day
  • having not initiated weaning foods or beverages other than infant formula or breast milk
  • study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
  • informed consent signed(parent/legal representative)

Exclusion Criteria:

  • Chromosomal or major congenital anomalies
  • known cow's milk allergy
  • receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
  • receiving an antibiotic or probiotic in the week prior to enrollment
  • complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
  • infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
  • infant currently participating in another conflicting clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01017991
Other Study ID Numbers  ICMJE 09.03.INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael D Cabana, MD,MPH University of California, San Francisco, USA
PRS Account Nestlé
Verification Date November 2017

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