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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01987154

Enrollment

Registered

2013-11-19

Start date

2014-02-28

Completion date

2016-03-31

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Intolerance

Brief summary

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

Interventions

OTHERMarketed cow milk-based premature infant formula

OTHERMarketed extensively hydrolyzed casein infant formula

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026