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

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

Study Overview

• Status: Completed
• Conditions: Feeding Intolerance
• Intervention / Treatment: Other: Marketed cow milk-based premature infant formula; Other: Marketed extensively hydrolyzed casein infant formula

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Enteral intake (ml/kg/day)	Daily for 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight (g)		Daily for 14 days
Feeding Tolerance	Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)	Daily for 14 days
Respiratory status	Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation	Daily for 14 days
Gut Inflammation	Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound	Once at Study Day 14
Confirmed or suspected sepsis or necrotizing enterocolitis		Daily for 14 days
Date of hospital discharge		Once at hospital discharge
Growth	length (cm) and head circumference (cm)	Study Days 1, 7, and 14

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Principal Investigator: Mariella Baldassarre, M.D., Università degli Studi di Bari

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 19, 2013

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: 6020