Probiotics/TPN in the NICU

NCT04977817 | Completed

• 1 other identifier: 822180615
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Parenteral Nutrition; Necrotizing Enterocolitis of Newborn

Outcome Measures

Primary Outcomes (1)

• Number of days on total parenteral nutrition

  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 Outcomes (2)

• Impact on neonatal growth

  30 days

• Feeding Intolerance

  30 days

Other Outcomes (5)

• Incidence of NEC

  30 days

• Days on Respiratory Support

  30 days

• Incidence of culture positive sepsis

  30 days

Study Arms (2)

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

Interventions

Similac Probiotic Tri-Blend DIETARY_SUPPLEMENT

Probiotic dietary supplement, Similac Probiotic Tri-Blend

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Birth weight \< 1500 grams or GA \< 32 weeks

You may not qualify if:

• Life threatening congenital anomalies
• Transfers to another facility prior to discharge home
• Investigator discretion to exclude if deemed necessary

Sponsors & Collaborators

• Pediatrix: lead
• Phoenix Children's Hospital: collaborator
• Banner University Medical Center: collaborator

Study Sites (2)

Banner Children's at Desert

Mesa, Arizona, 85202, United States

Location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (5)

• Jacobs SE, Tobin JM, Opie GF, Donath S, Tabrizi SN, Pirotta M, Morley CJ, Garland SM; ProPrems Study Group. Probiotic effects on late-onset sepsis in very preterm infants: a randomized controlled trial. Pediatrics. 2013 Dec;132(6):1055-62. doi: 10.1542/peds.2013-1339. Epub 2013 Nov 18.

  PMID: 24249817 BACKGROUND

• Gray KD, Messina JA, Cortina C, Owens T, Fowler M, Foster M, Gbadegesin S, Clark RH, Benjamin DK Jr, Zimmerman KO, Greenberg RG. Probiotic Use and Safety in the Neonatal Intensive Care Unit: A Matched Cohort Study. J Pediatr. 2020 Jul;222:59-64.e1. doi: 10.1016/j.jpeds.2020.03.051. Epub 2020 May 14.

  PMID: 32418818 BACKGROUND

• Patel RM, Underwood MA. Probiotics and necrotizing enterocolitis. Semin Pediatr Surg. 2018 Feb;27(1):39-46. doi: 10.1053/j.sempedsurg.2017.11.008. Epub 2017 Nov 6.

  PMID: 29275816 BACKGROUND

• Singh B, Shah PS, Afifi J, Simpson CD, Mitra S, Dow K, El-Naggar W; Canadian Neonatal Network Investigators. Probiotics for preterm infants: A National Retrospective Cohort Study. J Perinatol. 2019 Apr;39(4):533-539. doi: 10.1038/s41372-019-0315-z. Epub 2019 Jan 28.

  PMID: 30692619 BACKGROUND

• Sawh SC, Deshpande S, Jansen S, Reynaert CJ, Jones PM. Prevention of necrotizing enterocolitis with probiotics: a systematic review and meta-analysis. PeerJ. 2016 Oct 5;4:e2429. doi: 10.7717/peerj.2429. eCollection 2016.

  PMID: 27761306 BACKGROUND

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suganya Kathiravan, MD

  Phoenix Perinatal Associates - Neonatal Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 27, 2021
• Study Start: November 3, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 26, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (2)