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Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987154
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 19, 2013
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Enteral intake (ml/kg/day) [ Time Frame: Daily for 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Body Weight (g) [ Time Frame: Daily for 14 days ]
  • Feeding Tolerance [ Time Frame: Daily for 14 days ]
    Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)
  • Respiratory status [ Time Frame: Daily for 14 days ]
    Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation
  • Gut Inflammation [ Time Frame: Once at Study Day 14 ]
    Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound
  • Confirmed or suspected sepsis or necrotizing enterocolitis [ Time Frame: Daily for 14 days ]
  • Date of hospital discharge [ Time Frame: Once at hospital discharge ]
  • Growth [ Time Frame: Study Days 1, 7, and 14 ]
    length (cm) and head circumference (cm)
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 Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
Official Title  ICMJE Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
Brief Summary To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Feeding Intolerance
Intervention  ICMJE
  • Other: Marketed cow milk-based premature infant formula
  • Other: Marketed extensively hydrolyzed casein infant formula
Study Arms  ICMJE
  • Active Comparator: Marketed cow milk-based premature infant formula
    Intervention: Other: Marketed cow milk-based premature infant formula
  • Experimental: Marketed extensively hydrolyzed casein infant formula
    Intervention: Other: Marketed extensively hydrolyzed casein 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2013)
60
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premature infant 28 to 33 weeks gestational age, inclusive, at birth
  • Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
  • Birth weight is greater than or equal to 700g to 1750g
  • Appropriate birth weight for gestational age
  • Singleton or twin birth
  • Signed Informed consent

Exclusion Criteria:

  • Infant's mother plans to exclusively breast feed
  • 5 minute APGAR score is less than or equal to 4
  • Major surgery that required general anesthesia prior to randomization
  • Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
  • Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
  • Infant is currently participating in another clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987154
Other Study ID Numbers  ICMJE 6020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mead Johnson Nutrition
Study Sponsor  ICMJE Mead Johnson Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mariella Baldassarre, M.D. Universita degli Studi di Bari
PRS Account Mead Johnson Nutrition
Verification Date May 2016

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