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| Name | Class |
|---|---|
| Phoenix Children's Hospital | OTHER |
| Banner University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Similac Probiotic Tri-Blend | Dietary Supplement | Probiotic dietary supplement, Similac Probiotic Tri-Blend |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on neonatal growth | Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit. | 30 days |
| Feeding Intolerance | The administration of probiotics may change the incidence of feeding intolerance |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of NEC | Probiotic administration may change the incidence of Necrotizing Enterocolitis | 30 days |
| Days on Respiratory Support | Days on respiratory support may represent an indication of overall outcomes in the Neonatal Intensive Care Unit |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Suganya Kathiravan, MD | Phoenix Perinatal Associates - Neonatal Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Children's at Desert | Mesa | Arizona | 85202 | United States | ||
| Banner University Medical Center Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24249817 | Background | 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. | |
| 32418818 | Background |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 30 days |
| 30 days |
| Incidence of culture positive sepsis | Probiotic administration may change the incidence of culture positive sepsis | 30 days |
| 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 |
| All causes of Mortality | Probiotic administration may change the incidence of mortality in the Neonatal Intensive Care Unit. | 30 days |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| 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. |
| 29275816 | 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. |
| 30692619 | 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. |
| 27761306 | 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. |