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April 2013

Greetings from the Prolacta Team

LATCH… "to acquire understanding of, to comprehend"

"It just won’t go away!" states Dr. Lucky Jain, MD. MBA in the foreword to the latest edition of the Clinics in Pernatology for March 2013. Dr. Jain is writing about necrotizing entocolitis and goes on to state that "in spite of concerted efforts by researchers and clinicians everywhere, necrotizing enterocolitis (NEC) continues to be a devastating neonatal disease worldwide." The new edition presents an impressive array of articles describing the latest research and clinical practices to reduce the incidence and impact of NEC.

But Dr. Jain goes on to ask an interesting question in his forword "Why is it that simple measures that can significantly reduce the incidence and severity of this disease continue to be ignored?" (Clin Perinatol 40 (2013) xvii-xix http://dx.doi.org/10.1016/j.clp.2013.01.001) . He lists those simple measures as (1) the increased or exclusive use of human milk in very low birth weight infants; (2) the use of standardized feeding protocols to guide nutritional practice in the neonatal intensive care unit (NICU); and (3) normalizing the infant’s microbiome.

We at Prolacta Bioscience are dedicated to the use of human milk, including an exclusive human milk-derived human milk fortifier, in the nutritional management of very low birth weight infants (VLBW). We welcome and applaud this timely collection of studies and clinical practice strategies to prevent and reduce the life long impact of this disease on this helpless patient population.

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

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

Necrotizing Enterocolitis in Term Infants

Necrotizing enterocolitis (NEC) is primarily described as occurring among premature and low birth weight infants. A review of term infants with NEC from the Intermountain Healthcare hospitals was recently described (Christensen RD, Lambert DK, Baer VL et al. Necrotizing Enterocolitis in Term Infants Clin Perinatol 40 (2013) 69-78 http://dx.doi.org/10.1016/j.clp.2012.12.007. The authors stratified two periods of review: a First Epoch (2001-2006) and a Second Epoch (2006-2011). The infants were greater than 36 weeks’ gestation with one or more of the following clinical signs (1) bilious aspirate or emesis, (2) abdominal distention, (3) occult or gross blood in stool and one or more of the following radiographic signs (1) pnematosis intestinalis, (2) hepatobilliary gas, and (3) pneumoperitoneum. Infants with a surgical finding of isolated gastrointestinal perforation were not listed as NEC.

Three findings were of potential importance in identifying the mechanism of insult: (1) NEC occurred almost exclusively in neonates admitted to the NICU for some other reason; (2) Certain admission diagnoses were statistically more common i.e., congenital heart disease (particularly ductal-dependent lesions), polycythemia, and early-onset sepsis; and (3) NEC was much more common if the neonate was fed cow’s milk-based formulas, particularly in large volumes. The authors proposed these features could be united into a common pathogenesis: "neonates admitted to an NICU with conditions involving reduced mesenteric perfusion and fed large volumes of cow’s milk formulas in the first days of life."

Findings in the Second Epoch mirrored those in the previous group in that NEC occurred exclusively among those infants who had been admitted to the NICU for some other reason. The admitting diagnoses included respiratory distress, suspected congenital heart disease and sepsis. However, in the Second Epoch group 9 of the 22 term infants were undergoing management for withdrawal from opioid narcotics during gestation. There was also a change in the day-of-life in which NEC was recognized with a more rapid development of NEC in the subgroup with narcotic withdrawal.

Surgical NEC: Outcomes by Intestinal Location of Disease

Higher mortality rates among infants requiring surgical management of NEC have been reported when compared with those infants treated medically. An estimated 20% to 40% of infants who develop NEC will require surgical intervention, and the mortality rate in those infants is as high as 50%. Any portion of the gastrointestinal tract is at risk for the development of NEC. The pattern of involvement can be focal, patchy or diffuse and the distal small bowel and proximal large bowel are the sites most often affected.

Researchers at Johns Hopkins University School of Medicine and the Department of Surgery at the University of California San Diego investigated whether the outcomes of infants with surgically managed NEC differ according to whether the location of NEC in the small bowel (SB), large bowel (LB), or both (SB&LB). A retrospective analysis was performed using the Healthcare Cost and Utilization Project Nationwide Inpatient Sample (NIS) and Kids Inpatient Database (KID). Both databases were developed as part of the Healthcare Cost and Utilization Project (HCUP) of the Agency for Healthcare Research and Quality. Data collected from both databases included demographics, diagnosis, procedure information, insurance status, admission source, mortality, length of stay (LOS) and total hospital charges (Journal of Pediatric Surgery (2011) 46, 1475-1481 http://dx.doi.org/10.1016/j.jpedsurg.2011.03.005).

In-hospital mortality was 30.89% overall with 23.61% in the SB group, 15.26% in the LB group, and 22.85% in the SB&LB group. There was a significant statistical difference when comparing the SB group with the LB group (P < .001). The mean- LOS was 72.17 days overall, highest in the SB group (86.61 days) and lowest in the LB group (65.26 days). These differences were all statistically significant when comparing SB with LB (P < .001). The SB group had a 15.37-day longer LOS compared with the LB group (P < .001).The mean total hospital charges were $431,663 overall, $513,875 for the SB group, $393,798 for the LB group and $451,519 for the SB&LB group. These differences were statistically significant when making comparisons between the SB and LB groups (P < .001). For total hospital charges the SB group was $89,635 higher than the LB group. With regards to the outcomes of in-hospital mortality, LOS, and total hospital charges, the LB group fared the best. The SB group fared the worst with respect to LOS and total hospital charges.

Prevention of NEC: Role of Standardized Feeding Protocols

Avoiding a single case of surgical NEC could dramatically reduce the financial burden of prematurity at an approximate savings of $125,000 per case conservatively (Zhang Y, et al 2011; Ganapathy V, Hay JW, & Kim JH, Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012 Feb;7(1):29-37. doi: 10.1089/bfm.2011.0002. Epub 2011 Jun 30. Many of the risk factors contributing to NEC helplessness are non-modifiable such as prematurity, sepsis, patent ductus arteriosus, and red blood cell transfusion.

The question has been raised by Dr. Robert Christensen in the article "Can We Cut the Incidence of Necrotizing Enterocolitis in Half Today?" (Fetal and Pediatric Pathology, 29:185–198, 2010) whether adoption of two clinical practices – near-exclusive human milk feeding and the use of standardized feeding protocols may be modifiable risk factors for NEC. Sullivan et al Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine Milk-Based Products J Pediatrics 2010; 156(4):562-567.e1.) Have demonstrated the effectiveness of an exclusive human milk diet, including the use of an exclusive human milk-based fortifier, in reducing the risk of NEC and surgical NEC in infants weighing between 500g and 1250g at birth when compared to those infants receiving cow milk-based human milk fortifier or when mother’s milk was unavailable, preterm infant formula.

Standardized feeding protocols (SFPs) are a written set of feeding orders that replace the daily writing of feeding orders and provide the bedside nurse with specific instructions regarding the volumes to be fed and when milk fortifiers are to be added (Christensen, 2010). Over 10 years ago, Dr. Shanhirose Premji and colleagues published the first evidenced-based feeding guideline for infants weighing less than 1500 g ((Evidence-based feeding guidelines for very low-birth-weight infants. Advances in Neonatal Care 2002;2(1):5-18). SFPs apply consistent approaches to various clinical practices including the importance of supporting mothers to provide colostrum and human milk for their infant. While it is not completely clear how adopting feeding guidelines reduces the incidence of NEC, Christensen speculates that SFPs improve consistency of care and focuses the attention of the entire NICU staff on the importance of careful and deliberate enteral nutrition (Christensen, 2010, p. 190). Patole and de Klerk (Impact of standardised feeding regimens on incidence of neonatal necrotising enterocolitis: a systematic review and meta-analysis of observational studies. Arch Dis Child Fetal Neonatal Ed. 2005;90(2):F147-151) posited that the collaborative process of building the protocol, reviewing the evidence, and standardizing the approach to clinical situations specific to feedings issues may ultimately be responsible for the elimination of NEC. In February of this year Gephart & Hanson published an Evidence-Based Practice Brief (Preventing Necrotizing Enterocolitis With Standardized Feeding Protocols: Not Only Possible, But Imperative Advances in Neonatal Care 2013;13(1):48-56) summarizing the role of SFPs. In addition to the impact on NEC, SFPs have been demonstrated to reduce the time to achieve full enteral feeding volumes, days of parenteral nutrition, days of indwelling central catheters and incidence of central line infections. Although randomized control trials could not be identified, the mounting weight of observational evidence demonstrates a protective effect of feeding protocols.

Does NICU Design Influence a Mother’s Expressing Milk for Her Preterm Infant

Extensive research supports the specific benefits of breast milk for high-risk preterm infants. The most recent recommendation of the American Academy of Pediatrics is that all preterm infants should receive human milk feedings (Breastfeeding and the Use of Human Milk http://pediatrics.aappublications.org/content/129/3/e827). Mothers of hospitalized preterm infants initiate milk production through either manual expression or use of a breast pump 8 to 10 times per day, followed by milk expression 6 to 8 times per day to maintain their milk supply. Sweet (Expressed breast milk as 'connection' and its influence on the construction of 'motherhood' for mothers of preterm infants: a qualitative study. Int Breastfeed J. 2008;3:30 ) found that mothers initiated and continued milk expression to be physiologically and emotionally close to their babies and felt that it was a reflection of being a good mother and doing what was necessary for the baby. Mothers have identified that a lack of discretion and the need to travel to see their infants interfered with pumping.

A recent architectural change seen in the NICU is the movement from multi-bed rooms to single-family designs or single-patient rooms (SFR). Dowling, Blatz, & Graham note that few studies have examined factors that contribute to an increased duration of milk expression by mothers of preterm infants (Mothers' Experiences Expressing Breast Milk for Their Preterm Infants: Does NICU Design Make a Difference? Advances in Neonatal Care 2012;12(6):377-384). They designed a descriptive comparative design study comparing 2 groups of mothers (15 in the original NICU) and 25 in the SFR NICU) recruited 2 months before and 3 months after opening an SFR NICU. Nutritional data was collected throughout hospitalization. The mothers used a milk expression diary during hospitalization and completed a survey immediately before infant discharge.

The majority of the mothers (55%) were most comfortable pumping in their own homes because of the increased discretion and control of the environment.

There were no statistically significant differences between the 2 groups regarding the place where they were most comfortable pumping or where they usually pumped, although more mothers pumped in their babies’ rooms in the SFR nursery. At discharge 71.8% of the total group was providing some breast milk and 44.7% of the total group was providing breast milk exclusively. There was no significant difference between the groups concerning the provision of breast milk. The authors note that in addition to obtaining and learning to use a breast pump, mothers need a long term plan to ensure their milk supply. This plan should include discussion of how a mother can fit milk expression into her daily routine, determination of where she feels would be the ideal location to pump, and provision of adequate discretion.

To learn more about Prolacta's human milk products, please go to www.prolacta.com.