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

Study Overview
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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.

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

Conditions
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Pre-term Infants

Intervention / Treatment
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* Other: study pre-term formula


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study pre-term formula<br>Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles | Other: study pre-term formula<br>* 24 kcal/fl oz pre-term formula for in-hospital use<br>* Other names: Similac Special Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain per day | weight gain per day (g/kg/d) | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length | Growth, change in length | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | 
| Daily Stool Questionnaire | Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured. | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | 
| Serum Calcium | Blood biochemistries | SDAY 1, 15, and 29 or hospital discharge (whichever comes first) | 
| Head circumference | Growth, change in head circumference | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | 
| Daily Feeding Questionnaire | Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured. | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | 
| Any periods of nil per os (NPO) | Gastro-Intestinal Tolerance | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | 
| Phosphorus | Blood biochemistries | SDAY 1, 15, and 29 or hospital discharge (whichever comes first) | 
| Alkaline Phosphatase | Blood biochemistries | SDAY 1, 15, and 29 or hospital discharge (whichever comes first) |