Probiotics/TPN in the NICU

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants < 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.

Official Title
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A Prospective/Retrospective Chart Review of the Effects of a Probiotic Dietary Supplement on Days of Total Parenteral Nutrition in Two Neonatal Intensive Care Units

Conditions
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Total Parenteral Nutrition, Necrotizing Enterocolitis of Newborn

Intervention / Treatment
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* Dietary Supplement: Similac Probiotic Tri-Blend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight < 1500 grams or GA < 32 weeks Exclusion Criteria: Life threatening congenital anomalies Transfers to another facility prior to discharge home Investigator discretion to exclude if deemed necessary
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>By using the Baby Steps Program, neonates less than or equal to 1500 grams and less than 32 weeks GA will be identified. The control group will contain those that did not receive probiotics. | |
| Treatment Group<br>By using the Baby Steps Program, neonates less than or equal to 1500 grams and less than 32 weeks GA will be identified. The treatment group will contain those neonates that did receive the probiotic nutritional supplement. | Dietary Supplement: Similac Probiotic Tri-Blend<br>* Probiotic dietary supplement, Similac Probiotic Tri-Blend<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days on total parenteral nutrition | Evaluate the effects of a probiotic dietary supplement (Similac Probiotic Tri-Blend) on number of days on total parenteral nutrition (TPN) in infants admitted to the Neonatal Intensive Care Unit (NICU). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on neonatal growth | Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit. | 30 days | 
| Feeding Intolerance | The administration of probiotics may change the incidence of feeding intolerance | 30 days |