Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-25

Brief Summary

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This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.

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Detailed Description

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When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.

Conditions

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Infant, Premature, Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Formula

Standard formula for preterm infants.

Group Type ACTIVE_COMPARATOR

Standard formula for preterm infants

Intervention Type OTHER

Reconstituted in water and given to infants at more than 50% of feedings.

Experimental formula

Formula with higher protein and new fat blend for preterm infants.

Group Type EXPERIMENTAL

Formula with higher protein and new fat blend for preterm infants

Intervention Type OTHER

Reconstituted in water and given to infants at more than 50% of feedings.

Interventions

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Standard formula for preterm infants

Reconstituted in water and given to infants at more than 50% of feedings.

Intervention Type OTHER

Formula with higher protein and new fat blend for preterm infants

Reconstituted in water and given to infants at more than 50% of feedings.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Less than or equal to 33 weeks 0 days
* Birth weight less than or equal to 2000g.
* Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
* At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
* Written informed consent has been obtained from the parent/legally authorized representative (LAR).

Exclusion Criteria

* Peri-/intra-ventricular hemorrhage
* Renal disease
* Hepatic dysfunction
* Major congenital malformations
* Suspected or documented systemic or congenital infections
* Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth
* Suspected or documented maternal substance abuse
* Infants who have received any experimental treatment or intervention

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No