Clinical trial NCT04977817: Probiotics/TPN in the NICU
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Parenteral Nutrition
Necrotizing Enterocolitis of Newborn
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Phoenix Children's Hospital
name: Banner University Medical Center
First posted: 2021-07-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of days on total parenteral nutrition
timeFrame: 30 days
Secondary outcomes:
measure: Impact on neonatal growth
timeFrame: 30 days
measure: Feeding Intolerance
timeFrame: 30 days
Other outcomes:
measure: Incidence of NEC
timeFrame: 30 days
measure: Days on Respiratory Support
timeFrame: 30 days
measure: Incidence of culture positive sepsis
timeFrame: 30 days
measure: Incidence of complication of central lines
timeFrame: 30 days
measure: All causes of Mortality
timeFrame: 30 days
Locations:
city: Mesa
country: United States
facility: Banner Children's at Desert
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Phoenix Perinatal Associates - Neonatal Division
name: Suganya Kathiravan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.