Probiotics/TPN in the NICU

August 26, 2022 updated by: Mednax Center for Research, Education, Quality and Safety

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Children's at Desert
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Dietary supplement: Similac Probiotic Tri-Blend
Probiotic dietary supplement, Similac Probiotic Tri-Blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days on total parenteral nutrition
Time Frame: 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).
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on neonatal growth
Time Frame: 30 days
Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit.
30 days
Feeding Intolerance
Time Frame: 30 days
The administration of probiotics may change the incidence of feeding intolerance
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of NEC
Time Frame: 30 days
Probiotic administration may change the incidence of Necrotizing Enterocolitis
30 days
Days on Respiratory Support
Time Frame: 30 days
Days on respiratory support may represent an indication of overall outcomes in the Neonatal Intensive Care Unit
30 days
Incidence of culture positive sepsis
Time Frame: 30 days
Probiotic administration may change the incidence of culture positive sepsis
30 days
Incidence of complication of central lines
Time Frame: 30 days
Probiotic administration may change the length of time that a central line will need to be in place.
30 days
All causes of Mortality
Time Frame: 30 days
Probiotic administration may change the incidence of mortality in the Neonatal Intensive Care Unit.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mednax Center for Research, Education, Quality and Safety

Collaborators

Phoenix Children's Hospital
Banner University Medical Center

Investigators

  • Principal Investigator: Suganya Kathiravan, MD, Phoenix Perinatal Associates - Neonatal Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 26, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 822180615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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