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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01987154
First Posted: November 19, 2013
Last Update Posted: May 17, 2016
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.
Information provided by (Responsible Party):
Mead Johnson Nutrition
  Purpose
To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

Condition Intervention
Feeding Intolerance Other: Marketed cow milk-based premature infant formula Other: Marketed extensively hydrolyzed casein infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Enteral intake (ml/kg/day) [ Time Frame: Daily for 14 days ]

Secondary Outcome Measures:
  • 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)


Enrollment: 61
Study Start Date: February 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marketed cow milk-based premature infant formula Other: Marketed cow milk-based premature infant formula
Experimental: Marketed extensively hydrolyzed casein infant formula Other: Marketed extensively hydrolyzed casein infant formula

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987154


Locations
Italy
Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari
Bari, Apulia, Italy, 70124
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Mariella Baldassarre, M.D. Universita degli Studi di Bari
  More Information

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01987154     History of Changes
Other Study ID Numbers: 6020
First Submitted: November 5, 2013
First Posted: November 19, 2013
Last Update Posted: May 17, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action


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