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October 2013

Greetings from the Prolacta Team

LATCH… "to acquire understanding of, to comprehend"

Prolacta Bioscience's eNewsletter serves to extend our mission of "making a meaningful difference in the lives of thousands of the most vulnerable infants through world class research and innovative products" by providing the health care professional with a brief overview of evolving research, current clinical issues and emerging strategies relevant to the care of the premature infant and sick newborn.

The interest, evidence, and clinical use of a mother’s own milk (MOM), donor human milk (DM) and a human milk-based human milk fortifier (Prolact+2HMF) to provide a completely human milk diet (CHMD) for low birth-weight infants continues to grow. Prolacta Bioscience is dedicated to the use of human milk, including an exclusive human milk-derived human milk fortifier, in the nutritional management of this vulnerable population. And we are equally as proud to be affiliated with the many healthcare professionals and clinical sites that champion and drive this change in practice every day. However, at this particular point in time – October 2013 - we are possibly most proud of our commitment to “advancing the science of human milk”.

In three unique and groundbreaking accomplishments this month we at Prolacta Bioscience are revolutionizing the clinical practice, emerging research and manufacturing standard for the use of human milk in the NICU.

The first is the grand opening of Prolacta Bioscience’s new 67,000 square foot, state-of-the-art human milk processing facility in City of Industry, CA. This facility will house the world’s largest human milk freezer, state-of-the-art laboratory facilities, and biological grade milk processing suites enabling Prolacta to expand its human milk product offerings.

The second involves Prolacta’s hosting of the 1st International Conference on Human Milk Science and Innovation in Santa Monica, CA on October 24 & 25th. This meeting will be the first of what is planned to be a bi-annual symposium and platform for leading researchers and clinicians from around the world to discuss the merits of human milk, explore the evidence for human milk-based nutritional strategies for the extremely low birth weight infant and share ideas for future therapeutic innovations.

And last but certainly not least, we will review two recent publications regarding company-sponsored studies in which Prolacta played an active role. The first, appearing in the Journal of Pediatrics, examines the benefits of a completely human milk diet (CHMD) in reducing the number of days on Total Parenteral Nutrition (TPN) and an associated lower incidence of surgery associated with NEC. This study follows landmark 2009 study by Sullivan, et al that demonstrated the benefits of an exclusive human milk based diet including a human milk-based human milk fortifier.

The second publication, appearing in BMC Pediatrics, examined the long term health care costs associated with both medical and surgical Necrotizing Enterocolitis (NEC). The authors demonstrated a reduction in health care costs and a reduced risk of developing later pediatric health care problems if NEC can be prevented.

Please join us in celebrating these events that support the mission of Prolacta Bioscience to make “a meaningful difference in the lives of thousands of the most helpless infants through world class research and innovative products".

Terry S. Johnson, APN, NNP-BC, MN, CLEC
Neonatal Nurse Practitioner
Editor, Prolacta eNewsletter

Exclusive Human Milk Diets in Extremely Premature Infants

A recent study to compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM) was recently published in the Journal of Pediatrics

The multicenter randomized controlled trial studied extremely preterm infants whose mothers did not provide their milk. Birth weight (983 vs 996 g) and gestational age (27.5 vs 27.7 wk), in the BOV and HUM, groups respectively were similar. There was a significant difference in median parenteral nutrition days: 36 vs 27, in BOV vs HUM, respectively (P =.04). The incidence of necrotizing enterocolitis (NEC) in BOV was 21% (5 cases) vs 3% in HUM (1 case), P = 0.8.The incidence of surgical NEC was significantly higher in BOV (4 cases) vs HUM (0 cases), P =.04. This double-blind study demonstrated that extremely premature infants (<1250g) who are fed an exclusive human milk diet instead of preterm formula require fewer days of intravenous feedings through total parenteral nutrition (TPN) and have a significantly lower incidence of surgery associated with (NEC). It should be noted that the trial involved exclusively donor milk and donor milk-based products, thus answering the question of whether donor milk is protective in this setting. The trial provided a clear comparison of the effects of preterm formula versus human milk and supported the use of an exclusive human milk diet (EHMD) for extremely preterm infants in the neonatal intensive care unit (NICU).

This study follows the landmark 2009 study published in the Journal of Pediatrics, which concluded that for very low-birth-weight preterm infants weighing less than 1250 grams, an exclusively human milk- based diet (EHMD) was associated with significantly lower rates of NEC and surgical NEC, when compared to very low-birth-weight preterm infants who received a diet that included bovine milk-based products.

NICU Breast Milk Warming Practices

Many preterm infants are unable to directly breastfeed which requires that their mothers must pump their milk and freeze it for later use. While there are guidelines for the safe storage and thawing of frozen human milk these do not address the issue of safe temperature variations in warming baths or the length of time that milk can safely remain in warming baths. A recent study by Dumm, et al in Advances in Neonatal Care described NICU nurses’ current practice of warming human feedings, and observed the physiologic response of neonates to varied feeding temperatures.

Randomly selected experienced neonatal nurses (n=61) in Level III NICUs were observed as they prepared and administered breast milk gavage feedings. Temperatures of the water bath and breast milk were measured at the beginning and end of the warming period. Inclusion criteria for the infants required that the infants be preterm and receive at least 5 mL of mother’s expressed milk or pasteurized donor milk by bolus gavage or bottle. The 33 preterm infants who received the warmed feedings were observed before feedings and at 5 minutes and 30 minutes after the start of the feedings. A baseline temperature, heart rate, oxygen saturation from the monitor, and an observed respiratory rate were recorded within an hour prior to the feeing. Gastric residuals were measured 3 hours after the feedings were completed. Gestational age at birth of the 33 infants ranged from 25 weeks and 1 day to 35 weeks and 5 days (mean = 30.4 ± 3.2 weeks) and birth weight ranged from 735 g to 2992 g (mean = 1751 ± 456 g) and the infants’ postnatal age when observed was 3 to 76 days (mean = 28 ± 21 days).

Water bath temperatures ranged from 23.3°C to 45.5°C at the start of the warming and from 23.8°C to 38.4°C when the milk was removed. Refrigerated milk was 3.8°C to 27.1°C and warmed to 21.8°C to 36.2°C before feeding. Warming times ranged from 133 to 3061 seconds. The infants axillary temperatures were increased at 5 and 30 minutes into the feedings (P=.05), while heart rate, respirations and oxygen saturation showed no significant changes.

Pasteurized Human Donor Milk Use in the US

The American Academy of Pediatrics policy statement on Breastfeeding and the Use of Human Milk states that the “potent benefits of human milk are such that all preterm infants should receive their own mother’s milk, fresh or frozen, as their primary diet. If a mother’s own milk is unavailable despite significant lactation support, pasteurized donor milk should be used and it should be fortified appropriately for the infant born weighing less than 1.5 kg”.

Pasteurized human donor milk (DM) use is increasing rapidly. A study recently published in the Journal of Human Lactation by Parker, et al notes that eighty-five percent of DM programs in the United States Level III NICUs are less than or equal to 5 years old. The purpose of the study was to determine current use of DM in US Level III NICUs and to determine beliefs and predictors of DM use. The authors used a national mail survey of NICU medical directors in February of 2012 sent in a purposive random sampling to understand the patterns of human milk usage by geographic region. Part one of the survey assessed whether DM was used, NICU annual admissions, admission and management of surgical infants, systems to support human milk administration, collection and storage, and hospital characteristics. The second part of the survey was intended only for those facilities using DM to determine criteria for initiation and discontinuation of DM use. Items assessed included the consent process, refusal rates, payers, methods of prescribing and turnaround time to receive DM after ordering.

The final sample included 302 surveys sent to NICU medical directors ranging from 75 to 77 per geographic region and 60.3% (182 of 302) were completed. Forty-two percent of the responding Level III NICU medical directors reported use of DM in their NICU. Predictors of DM usage through multivariate analyses demonstrated that having greater than 800 annual NICU admissions was associated with a 4-fold higher odds of DM use. NICUs located in the Midwest and West were associated with a 3-fold and 6-fold higher odds of DM use, respectively, compared with the Northeast. The most commonly reported maternal factors for DM initiation were a mother’s inability to provide milk (85%) and insufficient supply of breast milk (81%) while the most commonly reported infant factors were infants below a specified birth weight (83%) and gestational age (75%). Fewer than half of the respondents felt that DM was nutritionally adequate and only 51% of DM milk users reported initiation after surgery. Safety-net hospitals (“substantial share“or greater than 75% of patients are uninsured or have Medicaid insurance) were less likely to use DM.

Long-Term Health Care Costs Associated with NEC

Necrotizing enterocolitis is the most common gastrointestinal emergency in neonates and remains a leading cause of neonatal morbidity and mortality. Approximately 20% to 30% of very low birth weight infants who develop NEC die and infants who survive the disease are at an increased risk of having poor long term physiological complications including cholestasis, recurrent sepsis, short bowel syndrome, and intestinal failure. In addition survivors of NEC are at an increased risk for neurodevelopmental impairment including abnormal neurologic exam, a low Bayley Psychomotor Development Index score, visual impairments, and cerebral palsy. The estimated financial impact of affected infants in the United States is between $500 million and $1 billion per year.

A recent study published in BMC Pediatrics, demonstrated increased long-term healthcare costs associated with medical necrotizing enterocolitis (NEC) and even greater costs with surgical NEC in extremely premature infants, as well as the significant increase in the odds of developing long-term health conditions. The study compared the long-term healthcare costs beyond the initial neonatal hospitalization period, from six months to three years of age, incurred by medical and surgical NEC survivors with that of premature infants who were not diagnosed with NEC. Data was obtained from Texas Medicaid databases for infants born between January 2002 and December 2003.

Two hundred fifty NEC survivors (73 with surgical NEC) and 2,909 matched controls were available for follow-up. Medical NEC infants incurred significantly higher healthcare costs than matched controls between 6-12 months of age (mean incremental costs = US$ 5,112 per infant). Surgical NEC survivors incurred healthcare costs that were consistently higher than that of matched controls through 36 months of age. The mean incremental health care costs of surgical NEC infants compared to matched controls between 6-12, 12-24, and 24-36 months of age were US$ 18,274, 14,067 (p < 0.01) and 8,501 (p = 0.06) per infant per six month period respectively.

The study led by Dr. Joel Hay with the department of clinical pharmacy & pharmaceutical economics & policy, from the University of Southern California, Los Angeles, California further concluded that costs savings related to the avoidance of NEC or surgical NEC could be as much as $40,000 per child.

The authors also demonstrated a reduced risk of developing further health problems if NEC is prevented. Within the group of preterm infants ages 6-12 months who were diagnosed with surgical NEC, those infants had four times greater odds of developing bronchopulmonary dysplasia (BPD) and 47 times greater odds of developing malabsorption syndrome. Within the group of preterm infants ages 24-36 months, those diagnosed with surgical NEC had more than a five times greater odds of developing BPD and 62 times greater odds of developing malabsorption syndrome.

The high costs among surgical NEC survivors were initially driven by inpatient expenditures. However, the frequency of hospital admissions and level of inpatient expenditures decreased over time. Home healthcare and other ambulatory care expenditures were the main drivers of costs among surgical NEC children from 1 to 3 years of age. Other significant conditions resulting from NEC or surgical NEC included various disorders of the gastrointestinal tract, neuro-developmental delays and cerebral palsy.

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