Total Parenteral NutritionNCT04977817
Probiotics/TPN in the NICU
An observational study of Total Parenteral Nutrition and Necrotizing Enterocolitis of Newborn, run by Pediatrix at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Parenteral Nutrition, Necrotizing Enterocolitis of Newborn
- What is being tested?
- Similac Probiotic Tri-Blend
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2021to 26 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Birth weight < 1500 grams or GA < 32 weeks
Who cannot join
- Life threatening congenital anomalies
- Transfers to another facility prior to discharge home
- Investigator discretion to exclude if deemed necessary
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Banner Children's at Desert
Mesa, Arizona, 85202
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
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
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.
- Being tested
- Similac Probiotic Tri-Blend
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Similac Probiotic Tri-BlendDietary supplement
Probiotic dietary supplement, Similac Probiotic Tri-Blend
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Similac Probiotic Tri-Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (2)
Impact on neonatal growth
Neonatal growth velocity may be impacted by the usage of probiotics in the Neonatal Intensive Care Unit.
Measured: 30 days
Feeding Intolerance
The administration of probiotics may change the incidence of feeding intolerance
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start3 Nov 2021
- Primary completion1 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix Children's Hospital, Banner University Medical Center
- Responsible party
- Sponsor
- Investigators
- Suganya Kathiravan, MD, Principal investigator, Phoenix Perinatal Associates - Neonatal Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977817
- Sponsor's protocol ID
- 822180615
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24249817Gray 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.
PubMed 32418818Patel 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.
PubMed 29275816Singh 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.
PubMed 30692619Sawh 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.
PubMed 27761306
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04977817
- Acronym / sponsor ID
- 822180615
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Phoenix Children's Hospital, Banner University Medical Center
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Dietary Supplement: Similac Probiotic Tri-BlendBy 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Birth weight < 1500 grams or GA < 32 weeks
Key exclusion criteria (3 listed)
- Life threatening congenital anomalies
- Transfers to another facility prior to discharge home
- Investigator discretion to exclude if deemed necessary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Similac Probiotic Tri-BlendProbiotic dietary supplement, Similac Probiotic Tri-Blend | Dietary supplement | Treatment Group |
Primary outcome
Number of days on total parenteral nutrition
Time frame: 30 days
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).
2 secondary outcomes
Impact on neonatal growth
Time frame: 30 days
Feeding Intolerance
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Background: PubMed 24249817Jacobs 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.
- Background: PubMed 32418818Gray 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.
- Background: PubMed 29275816Patel 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.
- Background: PubMed 30692619Singh 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.
- Background: PubMed 27761306Sawh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suganya Kathiravan, MD principal investigator
Phoenix Perinatal Associates - Neonatal Division
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Parenteral Nutrition and Necrotizing Enterocolitis of Newborn, run by Pediatrix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days on total parenteral nutrition (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04977817, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.