Probiotics QI Project

Probiotics to support the prevention of necrotizing enterocolitis         

Background
35 randomized controlled trials including > 10,000 premature infants and 12 cohort studies, including an additional > 13,000 premature infants, have demonstrated improved outcomes with probiotic administration including decreased risk of necrotizing enterocolitis, death, and feeding intolerance.

The goal of this quality improvement initiative is to monitor differences in key outcomes after adoption of routine use of various promising probiotic products. Primary outcomes include NEC, death, and sepsis (including sepsis related to the probiotic product). Secondary outcomes include days to full enteral nutrition, TPN days, change in weight z-score from birth to NICU discharge, and length of hospital stay. Probiotics are suggested based on evidence of efficacy, safety, and purity of the products, as well as to allow key comparisons (e.g. single organisms vs combination products, Lactobacillus vs Bifidobacterium). These probiotic products are briefly described here, although the choice of probiotic product is entirely at the discretion of the physician. The goal is participation by a large number of NICUs (60-100).  Steps to participate are as follows:

Step 1
Begin with a consensus meeting of your colleagues to ensure that all the neonatologists/hospitalists/NNPs are supportive and willing to treat all eligible babies with a probiotic product.

Step 2
Choose a probiotic product and obtain approval from your pharmacy committee to add this product to your hospital formulary.

Step 3
Discuss with your IRB whether this QI initiative requires IRB approval (many IRBs will categorize this as either “not human research” or “exempt”) and whether data are best collected prospectively or retrospectively.

Step 4
Register your NICU in the multi-center QI project here: click here to enroll.
Please complete the entire enrollment form. You will then be contacted to confirm your enrollment and will be provided a unique NICU study number.

Step 5
Collect data for an 18-month period (during which probiotic administration is not routine) on all babies born at < 1500 g and gestational age < 33 weeks. This can be done either prospectively or retrospectively.

You have two options for data collection. For either option, please use the Excel spreadsheet available here (tab 1, baseline) to ensure ease of data cleaning and analysis.  

Option one is to report just the primary outcomes (complete columns N, O, P, Q, R and V in the spreadsheet for each infant).

Option two is to complete all the columns in the spreadsheet. If you provide all the information (option two), the QI leader from your institution will be included as a co-author in the publication resulting from this QI project.

If you only provide the data in option one, your unit will be noted in the acknowledgement section of the publication.

Your unique NICU study number should replace X in column A

Step 6
Begin treatment of all babies with birth weight < 1500 g or gestational age at birth < 33 completed weeks. Start probiotic treatment with the onset of either feeding or oral/buccal colostrum and continue until 34 weeks corrected gestational age.

Signed consent from the parents is not necessary unless required by your IRB, but parents should be provided with the written summary available here (or a version that you have modified to meet the needs of your population) explaining the rationale behind provision of mother’s own milk, pasteurized donor human milk, and probiotics.  The probiotic can either be held or continued during periods of NPO and/or antibiotics at the discretion of the neonatologist.

Step 7
Collect data for an 18-month period on all babies with birth weight < 1500g or gestational age at birth < 33 completed weeks. Please report the same data as reported for the baseline period using the same Excel spreadsheet, tab 2, probiotic, i.e. either option one (just the primary outcomes) or option two (primary and secondary outcomes).  Your unique NICU study number should replace X in column A.

Step 8
Near the end of the probiotic administration period hold another consensus meeting of your colleagues to review your data and decide together whether to continue the selected probiotic, stop probiotic administration, or change to a different probiotic product.

It would be very helpful to continue data collection for 18 months, regardless of which choice is selected (Excel spreadsheet, tab 3). Your unique NICU study number should replace X in column A.

Step 9
Submit the completed Excel spreadsheet here. You can either upload the spreadsheet at the completion of the probiotic administration period, or following the third QI cycle (i.e. after completion of all three 18-month periods). The data will be kept in the cloud with access limited to NEC Society personnel.  The submitted version must have column B (patient identifier) deleted in each of the three data sheets prior to submission to ensure protection of privacy.  Keep a copy of the spreadsheet with the column B data in a secure location at your facility.

Please Note
This is not a clinical trial. There is no placebo arm, no randomization, and no blinding.  While this is not research, we believe the results of a multi-center QI project will be of interest to clinicians and researchers. The intention of the NEC Society is to support publication of the de-identified results in the medical literature. While there is no funding to support data collection, the more NICUs that provide the secondary outcomes data, the more helpful the final published data will be to the field.

Please Note
Routine probiotic administration to premature infants is not recommended by either the American Academy of Pediatrics or the US Food and Drug Administration. This QI project is recommended by the scientific advisory committee of the NEC Society based on a foundation of literature supporting the safety and efficacy of probiotic administration for the prevention of death, NEC, and sepsis in premature infants that has accumulated over the past decade.

The NEC Society and its scientific advisory committee do not endorse any particular probiotic product, do not imply that administration of probiotics is without risk, do not in any way guarantee results, and have no financial conflicts of interest to declare.

This QI project is not medical advice. All medical decisions are the responsibility of the physician and patient’s guardians.

For questions, suggestions or concerns please contact Dr. Mark Underwood at munderwood@ucdavis.edu

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