Probiotics/TPN in the NICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-08-26

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.

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Detailed Description

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Conditions

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Total Parenteral Nutrition Necrotizing Enterocolitis of Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Control Group

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.

No interventions assigned to this group

Treatment Group

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.

Similac Probiotic Tri-Blend

Intervention Type DIETARY_SUPPLEMENT

Probiotic dietary supplement, Similac Probiotic Tri-Blend

Interventions

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Similac Probiotic Tri-Blend

Probiotic dietary supplement, Similac Probiotic Tri-Blend

Intervention Type DIETARY_SUPPLEMENT

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No