Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital

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

PHASE2/PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.

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Detailed Description

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Conditions

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Pre-term Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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study pre-term formula

Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles

Group Type EXPERIMENTAL

study pre-term formula

Intervention Type OTHER

24 kcal/fl oz pre-term formula for in-hospital use

Interventions

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study pre-term formula

24 kcal/fl oz pre-term formula for in-hospital use

Intervention Type OTHER

Other Intervention Names

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Similac Special Care

Eligibility Criteria

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Inclusion Criteria

* Subjects eligible for study participation will satisfy the following criteria:

* Birth weight between 1000g -1800g
* Less than or equal to 34 weeks and 0 days gestational age at birth
* Appropriate for gestational age (AGA)
* Singleton or twin births
* Infant is 21 days of age or less

Exclusion Criteria

* Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:

* Expected to be transferred to another facility within 14 days
* Serious congenital abnormalities that may affect growth and development
* Intubated for ventilation at the time of study product initiation
* Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH)
* Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy
* Infant has a history of major surgery
* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia
* Confirmed necrotizing enterocolitis or confirmed sepsis
* Current use or planned use of probiotics
* Participation in another study that has not been approved

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No