Probiotics/TPN in the NICU

Completed

• Conditions: Total Parenteral Nutrition; Necrotizing Enterocolitis of Newborn
• Interventions: Dietary Supplement: Similac Probiotic Tri-Blend

• Registration Number: NCT04977817
• Lead Sponsor: Pediatrix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-27
• Study Start: 2021-11-03
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-26
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	Similac Probiotic Tri-Blend	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

Banner Children's at Desert; 🇺🇸 Mesa, Arizona, United States