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OpenTrials
Completed

NCT Number: NCT04977817

Probiotics/TPN in the NICU

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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Key information

Conditions

Total Parenteral Nutrition Hyperphagia Necrotizing Enterocolitis of Newborn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Children's at Desert, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Similac Probiotic Tri-Blend

Dietary Supplement

Probiotic dietary supplement, Similac Probiotic Tri-Blend

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. Feeding Intolerance

    Time frame: 30 days

    The administration of probiotics may change the incidence of feeding intolerance

Other outcomes

  1. Incidence of NEC

    Time frame: 30 days

    Probiotic administration may change the incidence of Necrotizing Enterocolitis

  2. 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

  3. Incidence of culture positive sepsis

    Time frame: 30 days

    Probiotic administration may change the incidence of culture positive sepsis

  4. 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.

  5. All causes of Mortality

    Time frame: 30 days

    Probiotic administration may change the incidence of mortality in the Neonatal Intensive Care Unit.

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Collaborators

  • Banner University Medical Center
  • Phoenix Children's Hospital

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2021
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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