Probiotics/TPN in the NICU

Necrotizing Enterocolitis of Newborn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977817
• Other study ID #: 822180615
• Status: Completed
• Start date: November 3, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: August 2022
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 26, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis of Newborn
• Total Parenteral Nutrition

Intervention

Dietary Supplement:
• Similac Probiotic Tri-Blend
Probiotic dietary supplement, Similac Probiotic Tri-Blend

Locations

Country	Name	City	State
United States	Banner Children's at Desert	Mesa	Arizona
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety	Banner University Medical Center, Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of NEC	Probiotic administration may change the incidence of Necrotizing Enterocolitis	30 days
Other	Days on Respiratory Support	Days on respiratory support may represent an indication of overall outcomes in the Neonatal Intensive Care Unit	30 days
Other	Incidence of culture positive sepsis	Probiotic administration may change the incidence of culture positive sepsis	30 days
Other	Incidence of complication of central lines	Probiotic administration may change the length of time that a central line will need to be in place.	30 days
Other	All causes of Mortality	Probiotic administration may change the incidence of mortality in the Neonatal Intensive Care Unit.	30 days
Primary	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	Impact on neonatal growth	Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit.	30 days
Secondary	Feeding Intolerance	The administration of probiotics may change the incidence of feeding intolerance	30 days