Probiotics/TPN in the NICU

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Brief Title

Probiotics/TPN in the NICU

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Number of days on total parenteral nutrition

Secondary Outcome

 Impact on neonatal growth

Condition

Total Parenteral Nutrition

Intervention

Similac Probiotic Tri-Blend

Study Arms / Comparison Groups

 Control Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

300

Start Date

August 6, 2021

Completion Date

September 2023

Primary Completion Date

September 2023

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Suganya Kathiravan, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04977817

Organization ID

822180615


Responsible Party

Sponsor

Study Sponsor

Mednax Center for Research, Education, Quality and Safety

Collaborators

 Phoenix Children's Hospital

Study Sponsor

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


Verification Date

August 2021