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Probiotics/TPN in the NICU

NCT04977817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-08-29

No results posted yet for this study

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.

Conditions

  • Total Parenteral Nutrition
  • Necrotizing Enterocolitis of Newborn

Interventions

DIETARY_SUPPLEMENT

Similac Probiotic Tri-Blend

Probiotic dietary supplement, Similac Probiotic Tri-Blend

Sponsors & Collaborators

  • Phoenix Children's Hospital

    collaborator OTHER

  • Banner University Medical Center

    collaborator OTHER

  • Pediatrix

    lead OTHER

Principal Investigators

  • Suganya Kathiravan, MD · Phoenix Perinatal Associates - Neonatal Division

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-08-01
Completion
2022-08-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04977817 on ClinicalTrials.gov