The Science Behind HDM Plus™ - Clinical Research & Studies

The Science

Learn about HDM Plus™ and the value of human donated milk.

The essence of science is testing

The promise of HDM Plus™ is triple testing for safety

Nursing Moms are Tested

Prior to becoming a donor, a nursing mom must be approved through a medical application and take a blood test. This is to ensure that the mom is free of any harmful contaminants, like drugs or alcohol, or blood borne pathogens.

Lab Testing to Ensure Safety

The next step in the testing process occurs prior to production of the donated breast milk. Unlike Community Milk Banks, Ni-Q performs lab testing prior to pooling, not after, to ensure all approved donor milk meets our standards. Every donation is tested for microbial contaminants, drugs and alcohol, and foreign milk proteins to ensure our patients are receiving 100% human milk.

Post Production Testing

Once production of our HDM product is complete, it is re-tested to ensure that it meets the highest levels of safety. We want to provide clinicians and new parents with the strongest levels of confidence in the donated milk they're receiving.

Advanced Safety Standards

3rd-Party Validation (and a lot more).

We are dedicated to providing nutrition to those who need it most, so our focus on safety is nothing new. With rigorous screening and testing protocols (backed by independent review of every batch), we protect you and your patients.

Consideration	NI-Q	FCMB (HMBANA)	Info
Commercially-Sterile			Ni-Q: With our proprietary stringent safety protocols, Ni-Q eradicates all viruses while maintaining nutrient viability. HMBANA: HMBANA donor milk is not commercially sterile and does not eradicate all viruses and bacteria, such as Bacillus Cereus or Botulism. (Lima, et al Study, 2017)
Advanced Initial Testing – Accepting Donors			Ni-Q: Ni-Q offers comprehensive donor screening protocols. Ni-Q requires its donors to pass microbial, alcohol, and drug testing panels, in addition to protein analysis to ensure the safety and validity of the donor milk. HMBANA: HMBANA performs a limited, one-time pre-screening for donors, covering the industry standards of HIV, HTLV, and Syphilis.
Donation Shipment Protection – Temperature Tracking			Ni-Q: Ni-Q utilizes temperature trackers in donor shipments to reduce the opportunity for bioburden contamination of donor milk. This ensures that each donation's temperature never exceeds 40°F. HMBANA: HMBANA does not offer any shipment temperature protections.
Advanced Forensic Level Testing – Approving Donations			Ni-Q: Prior to pooling and processing, Ni-Q tests every individual shipment received to ensure it meets our strict safety and quality requirements. Testing includes microbial, drug and alcohol, and protein analysis. 15% of the donor milk received does not pass this forensic level testing. HMBANA: HMBANA does not perform similar pre-production quality safety testing on the donor milk they receive.
Advanced Testing – Post-Processing			Ni-Q: Once a batch has been processed, Ni-Q performs a full range of microbial testing and detailed nutritional analysis using a third-party laboratory that's a leader in nutritional analysis. HMBANA: HMBANA simply tests for limited microbial contamination prior to refreezing its milk and shipment.
Removal of Bacillus Cereus Bacteria			Ni-Q: Agitated Retort Processing (used by Ni-Q) eradicates all traces of this bacteria. HMBANA: Holder pasteurization (used by HMBANA) has been shown in studies to not always effectively destroy Bacillus Cereus bacteria, which are toxins that can cause intestinal illness. (Lima, et al Study, 2017)

Guaranteed Nutrition

Quality & Growth When It Counts.

You should expect that your HDM provider has made every effort to deliver the best nutrition to you and your patients, especially with what's on the line. Unfortunately, that's not always the case.

Nutrition comes from calories, protein, and macro & micronutrients. Growth comes in the form of increased weight, improved skeletal maturity, bone density… and requires the proper nutrients. We understand this and use 3rd-party validation to ensure we always deliver quality nutrition. So every time you order or use Ni-Q products, you can be confident that we don't just say we deliver the proper nutrition; we guarantee it!

Consideration	NI-Q	FCMB (HMBANA)	Info
Shelf Stable – Ready to Feed			Ni-Q: Ni-Q products are completely shelf stable for up to 1 year and require no additional processing to use. Not frozen, so no thawing. HMBANA: HMBANA HDM is frozen so it requires thawing processing time and efforts, as well as freezer acquisition and maintenance costs.
Standardized Reliable Nutrition Every Time			Ni-Q: Ni-Q products offer standardized nutrition levels every time and guarantee nutritional levels at high levels of either 20 or 24 cal/oz (HDM Plus and HDM Boost, respectively) because we know NICU teams need to know the nutrition start point of its donor milk… every time! HMBANA: Regional Milk Banks do not have the ability to standardize every ounce of every bottle at any caloric count. This is due in large part to the small volume of milk per batch and their production model. As a result, calories/oz can vary from 13.1-16.6 cal/oz. (Individualizing Fortification of Human Milk Using Real Time Human Milk Analysis, Radmacher et al, Journal of Neonatal-Perinatal Medicine, 2013)
3rd-Party Nutrition Validation and Nutrition Labels provided			Ni-Q: To guarantee nutritional levels are achieved, Ni-Q employs a third-party nutrition validation company, Eurofins DQCI, to validate our nutritional content. This information is used to produce a detailed nutrition label so NICUs can have confidence in knowing their nutritional starting point. HMBANA: HMBANA does not obtain 3rd-party validation and does not always provide a detailed nutrition label for the content of its HDM.
5 days of usage after opening			Ni-Q: After opening, Ni-Q HDM can be used for up to 5 days with refrigeration to allow for efficient use of our HDM and minimize waste and cost. HMBANA: HMBANA HDM guidelines state that its donor milk should be used within 24hrs after thawing.
Homogenized			Ni-Q: Ni-Q HDM is homogenized so it delivers nutritional consistency of feeds, reduces clogging of feeding lines, and improves nutrient absorption. HMBANA: HMBANA products are not homogenized. Studies have shown unhomogenized human milk to result in inconsistent nutrition absorption experiences and feeding line clogging. (Ultrasonic Homogenization of Expressed Human Milk to Prevent Fat Loss During Tube Feeding, Martinez, et al, Journal of Pediatric Gastroenterology and Nutrition, 1987)