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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01987154
First received: November 5, 2013
Last updated: May 16, 2016
Last verified: May 2016
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body Weight (g) [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
  • Feeding Tolerance [ Time Frame: Daily for 14 days ] [ Designated as safety issue: No ]
    Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)

  • Respiratory status [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
    Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation

  • Gut Inflammation [ Time Frame: Once at Study Day 14 ] [ Designated as safety issue: No ]
    Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound

  • Confirmed or suspected sepsis or necrotizing enterocolitis [ Time Frame: Daily for 14 days ] [ Designated as safety issue: Yes ]
  • Date of hospital discharge [ Time Frame: Once at hospital discharge ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: Study Days 1, 7, and 14 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 5, 2013
Last Updated: May 16, 2016
Health Authority: Italian: Medicines Agency

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

ClinicalTrials.gov processed this record on September 29, 2016