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

Not Applicable

Completed

• Conditions: Feeding Intolerance
• Interventions: Other: Marketed cow milk-based premature infant formula; Other: Marketed extensively hydrolyzed casein infant formula

• Registration Number: NCT01987154
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Start: 2014-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Marketed cow milk-based premature infant formula	Marketed cow milk-based premature infant formula	-
Marketed extensively hydrolyzed casein infant formula	Marketed extensively hydrolyzed casein infant formula	-

Primary Outcome Measures

Name	Time	Method
Enteral intake (ml/kg/day)	Daily for 14 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari; 🇮🇹 Bari, Apulia, Italy