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Study in Unsettled Infants Experiencing Feeding Intolerance

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ClinicalTrials.gov Identifier: NCT02021058
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE November 22, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date January 31, 2017
Actual Study Start Date  ICMJE December 12, 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Changes from baseline to 14 days in fuss-cry behavior [ Time Frame: from baseline to 14 days ]
fuss-cry behavior per 24 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Change from baseline to 14 days in GI symptoms [ Time Frame: from baseline to 14 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 Study in Unsettled Infants Experiencing Feeding Intolerance
Official Title  ICMJE Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Brief Summary Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
Detailed Description The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
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: Treatment
Condition  ICMJE Feeding Disorder
Intervention  ICMJE
  • Other: Experimental Formula
    Experimental formula
  • Other: Standard control formula
    Standard Infant formula
Study Arms  ICMJE
  • Experimental: Experimental Formula
    Experimental Formula
    Intervention: Other: Experimental Formula
  • Standard Formula
    Standard Control formula
    Intervention: Other: Standard control formula
Publications * Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.

*   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
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)
259
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
260
Actual Study Completion Date  ICMJE August 23, 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Full term infants, singleton, healthy at birth
  2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
  3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
  4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.

Exclusion Criteria:

  1. Infants who are consuming any amount of supplemental human milk
  2. Infants who are consuming weaning foods or beverages other than infant formula
  3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
  4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance
  5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 90 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   Philippines,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021058
Other Study ID Numbers  ICMJE 13.10.INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University
PRS Account Nestlé
Verification Date January 2017

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