Necrotizing Enterocolitis of Newborn, Total Parenteral Nutrition
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSimilac Probiotic Tri-Blend
Probiotic dietary supplement, Similac Probiotic Tri-Blend
Sponsors
Phoenix Children's Hospital
Banner University Medical Center
Pediatrix
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days on total parenteral nutrition | 30 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on neonatal growth | 30 days | Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit. |
| Feeding Intolerance | 30 days | The administration of probiotics may change the incidence of feeding intolerance |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complication of central lines | 30 days | Probiotic administration may change the length of time that a central line will need to be in place. |
| Incidence of NEC | 30 days | Probiotic administration may change the incidence of Necrotizing Enterocolitis |
| All causes of Mortality | 30 days | Probiotic administration may change the incidence of mortality in the Neonatal Intensive Care Unit. |
| Days on Respiratory Support | 30 days | Days on respiratory support may represent an indication of overall outcomes in the Neonatal Intensive Care Unit |
| Incidence of culture positive sepsis | 30 days | Probiotic administration may change the incidence of culture positive sepsis |
Countries
United States
Outcome results
None listed