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

Feeding Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987154
• Other study ID #: 6020
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: May 16, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italian: Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Feeding Intolerance

Intervention

Other:
• Marketed cow milk-based premature infant formula

• Marketed extensively hydrolyzed casein infant formula

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari	Bari	Apulia

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enteral intake (ml/kg/day)		Daily for 14 days	Yes
Secondary	Body Weight (g)		Daily for 14 days	Yes
Secondary	Feeding Tolerance	Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)	Daily for 14 days	No
Secondary	Respiratory status	Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation	Daily for 14 days	Yes
Secondary	Gut Inflammation	Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound	Once at Study Day 14	No
Secondary	Confirmed or suspected sepsis or necrotizing enterocolitis		Daily for 14 days	Yes
Secondary	Date of hospital discharge		Once at hospital discharge	No
Secondary	Growth	length (cm) and head circumference (cm)	Study Days 1, 7, and 14	Yes