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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mead Johnson Nutrition
Information provided by (Responsible Party):
Mead Johnson Nutrition Identifier:
First received: November 5, 2013
Last updated: September 10, 2014
Last verified: September 2014

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
Primary Purpose: Supportive Care
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)

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01987154

Contact: Nancy Moore 8124831847

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

No publications provided

Responsible Party: Mead Johnson Nutrition Identifier: NCT01987154     History of Changes
Other Study ID Numbers: 6020
Study First Received: November 5, 2013
Last Updated: September 10, 2014
Health Authority: Italian: Medicines Agency

Additional relevant MeSH terms:
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on September 11, 2014