An observational study in Total Parenteral Nutrition and Necrotizing Enterocolitis of Newborn, sponsored by Pediatrix. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Pediatrix · Observational
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.
216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.
This study's enrollment of 150 is above the median of 78 across 86 observational studies indexed under Enterocolitis.
Browse Enterocolitis studies →Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.
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The subject population will be infants admitted to the Banner - University Medical Center Phoenix and Banner Children's at Desert NICUs who meet the specific inclusion criteria.
Exclusion Criteria:
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.
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
Probiotic dietary supplement, Similac Probiotic Tri-Blend
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).
Time frame: 30 days
Impact on neonatal growth
Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit.
Time frame: 30 days
Feeding Intolerance
The administration of probiotics may change the incidence of feeding intolerance
Time frame: 30 days
Incidence of NEC
Probiotic administration may change the incidence of Necrotizing Enterocolitis
Time frame: 30 days
Days on Respiratory Support
Days on respiratory support may represent an indication of overall outcomes in the Neonatal Intensive Care Unit
Time frame: 30 days
Incidence of culture positive sepsis
Probiotic administration may change the incidence of culture positive sepsis
Time frame: 30 days
Incidence of complication of central lines
Probiotic administration may change the length of time that a central line will need to be in place.
Time frame: 30 days
All causes of Mortality
Probiotic administration may change the incidence of mortality in the Neonatal Intensive Care Unit.
Time frame: 30 days
Plan to share: Undecided
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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