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NCT04977817 · ClinicalTrials.gov registry record

Probiotics/TPN in the NICU

A clinical trial of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition, sponsored by Pediatrix.

Completed
Registry status
150
Enrollment target
2
Study locations

NCT04977817 is a study of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition that has completed, run by Pediatrix. The registered enrollment target is 150 participants. The trial reports 2 study locations across 1 state.

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The verdict

NCT04977817, a study of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition, has completed, sponsored by Pediatrix.

COMPLETED
Registry status
150 participants
Enrollment target
2
Study locations

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.

Interventions

  • DIETARY_SUPPLEMENT Similac Probiotic Tri-Blend

Study Locations (2)

Arizona

  • Banner Children's at Desert - Mesa
  • Banner University Medical Center Phoenix - Phoenix

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2021-11-03
Est. Completion 2022-08-26

Sponsor

Pediatrix

28 total trials

What the Registry Record Tells You About NCT04977817

The ClinicalTrials.gov registry entry for NCT04977817 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pediatrix, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Necrotizing Enterocolitis of Newborn appearing as the primary indexed condition, and to 1 intervention - of which Similac Probiotic Tri-Blend is the first listed.

NCT04977817 reports 2 study locations spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT04977817 about?

NCT04977817 is a clinical study titled "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 captur...

What is the current status of trial NCT04977817?

This trial is currently completed. The enrollment target is 150 participants. The study started on 2021-11-03. Estimated completion is 2022-08-26.

What conditions does trial NCT04977817 study?

This clinical trial studies the following conditions: Necrotizing Enterocolitis of Newborn, Total Parenteral Nutrition.

What interventions are being tested in trial NCT04977817?

The interventions under investigation include: Similac Probiotic Tri-Blend (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04977817?

This trial is sponsored by Pediatrix, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04977817 being conducted?

This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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