NCT04977817

Probiotics/TPN in the NICU

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Pediatrix · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Total Parenteral Nutrition
• Necrotizing Enterocolitis of Newborn

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Similac Probiotic Tri-Blend	Probiotic dietary supplement, Similac Probiotic Tri-Blend

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-08-01
• Completion: 2022-08-26
• First posted: 2021-07-27
• Last updated: 2022-08-29

Locations

2 sites across 1 country: United States