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Page 1: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

© 2015 Prolacta Bioscience

Page 2: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

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© 2015 Prolacta Bioscience

Page 3: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Olivia Mayer

EDUCATION • Dietetic Internship, National Institutes of Health Clinical Center,

Bethesda, MD • B.S. in Nutrition (cum laude), Immaculata College, Malvern, PA

NATIONAL CERTIFICATIONS • Registered Dietitian • Board Certified as a Specialist in Pediatric Nutrition Publications • McCallie KR, Lee HC, Mayer O, Cohen RS, Hintz SR, Rhine WD.

Improved outcomes with a standardized feeding protocol for very low birth weight infants. Journal of Perinatology 2011; 31: S61S67.

• Cohen RC, Fogleman A, Mayer, O . Managing the HumanMilkFed, Preterm, VLBW Infant at NICU Discharge: A Simpler Way. ICAN: Infant, Child, & Adolescent Nutrition 2015; 7(4): 177179

• Interview: The benefits of early enteral feeding. Neonatal Intensive Care 2015;28 (3): 1819. © 2015 Prolacta Bioscience

Page 4: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Feeding Protocols: Standardizing Practice In the NICU Olivia Mayer RD, CSP

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•This presentation was created by, and reflects the sole opinions held by the presenter based on research and clinical experience.

•I received speaker honoraria from Prolacta Bioscience.

Disclosures

© 2015 Prolacta Bioscience

Page 6: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Feeding Protocols

•Why? •Literature Review •Clinical Experience •Practical Applications

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Feeding Protocols- Also Known As

•Feeding Pathway •Feeding Bundle •Standardized Feeding Initiation and Advancement •Standardized Enteral Feeding

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Early Enteral Feeding- Also Known As

•Trophic Feeds •Minimal Enteral Feeds (MEF) •Minimal Enteral Nutrition (MEN) •Gut Stim(ulating) Feeds •Non-nutritive Feedings •Small Volume Feeds •Early Enteral Nutrition

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Page 9: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Early Enteral Feeding

•Defined: –Preferred Feed: Human Milk –Rationale: stimulate gut hormone maturation, gut hormone release, and induce gut motility

–Volume: 10-30 mL/kg/day –Time Start: < 72 hours of life

•(IDEAL <24 hours of life) –Time Span: ≤5 days

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Page 10: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Why?

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Page 11: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Depiction of Gut Barrier Affected by Prolonged

NPO Status

Source: Strodtbeck F. The pathophysiology of prolonged periods of no enteral nutrition or nothing by mouth. Newborn and Infant Nursing Reviews 3(2); 47-52, 2003.

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Page 12: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Depiction of Intact Gut Barrier

Source: Strodtbeck F. The pathophysiology of prolonged periods of no enteral nutrition or nothing by mouth. Newborn and Infant Nursing Reviews 3(2); 47-52, 2003.

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Benefits of Early Enteral Feeding

•Fewer line days •Re-gain birth-weight faster •Promote GI maturity and tolerance •Improve bone mass by term age •Improved mental outcomes at 24 months corrected age

•Decreased length of hospital stay •Decrease cholestatic jaundice •Potentially achieve full feeds faster

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Page 14: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Contraindications

•Congenital anomalies precluding feeding (omphalocele, gastroschisis)

•Evidence of GI dysfunction associated with hypoxic-ischemic compromise

•Vasopressors •Indocin (?)

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Page 15: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Limitations

•Lactogenesis II (mom’s milk “coming in”) •Failure to appreciate the differences between the goals of trophic feeds versus nutritive feedings

•Inconsistent definition of “sick” infant •Complicated feeding protocols/algorithms for feeding intolerance

•Lack of buy-in from caregivers •Lack of access to banked breastmilk

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Page 16: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Literature Review

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Page 17: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Impact of Process Optimization and Quality Improvement Measures on Neonatal Feeding

Outcomes at an All-Referral Neonatal Intensive Care Unit

Process optimization and the implementation of a standardized feeding strategy minimize practice variability, accelerating the attainment of enteral and oral feeding milestones and decreasing LOS without increasing adverse morbidities.

Journal of Parenteral and Enteral Nutrition, 2015

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Page 18: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Early Enteral Feeding in Very Low Birth Weight Infants

•603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

•Early EF (defined as within the first 24 h) alone was significantly associated with decreased NEC or death and less PN days (p < 0.0001)

Hamilton E, et. al. Early enteral feeding in very low birth weight infants. Early Human Development; 90 (2014) 227–230

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Page 19: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Prevention of Postnatal Growth Restriction by the Implementation of an Evidence-Based Premature Infant

Feeding Bundle

The establishment and implementation of a standardized evidence-based feeding bundle for all VLBW infants in our NICU combined with ongoing monitoring and feedback resulted in a significant reduction in PNGR at time of discharge to home. These benefits were seen in ELBW infants as well, a group considered being at highest risk for PNGR.

Journal of Perinatology (2015) 35, 642–649

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Page 20: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Preventing Necrotizing Enterocolitis With Standardized Feeding Protocols Not Only

Possible, But Imperative

On the basis of that, SFPs are simple, cheap, effective, and transmissible; furthermore, they reduce the risk of NEC and it is time that adoption of SFP is no longer optional but imperative in the quest to prevent NEC.

Gephart SM; Hanson CK. Advances in Neonatal Care •2013; Vol. 13, No. 1 • pp. 48-54

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Page 21: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Impact of Standardized Feeding Regimens on Incidence of Neonatal Necrotizing

Enterocolitis: A Systematic Review and Meta-Analysis of Observational Studies

Conclusion: Standardized feeding regimens may provide the single most important global tool to prevent/ minimize NEC in preterm neonates. Randomized controlled trials are needed.

Gephart SM; Hanson CK. Advances in Neonatal Care •2013; Vol. 13, No. 1 • pp. 48-54

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Page 22: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Early Feeding & NEC

“These trials did not provide any evidence that early trophic feeding affected feed tolerance or growth rates. Meta-analysis did not detect a statistically significant effect on the incidence of necrotising enterocolitis: typical risk ratio 1.07 (95% confidence interval 0.67 to 1.70); risk difference 0.01 (-0.03 to 0.05).”

Morgan J, Bombell S, McGuire W. Early trophic feeding versus enteral fasting for very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2013 Mar 28;3:CD000504.

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Page 23: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

NEC

“The evidence available from randomized controlled trials suggests that delaying the introduction of progressive enteral feeds beyond four days after birth does not affect the risk of developing NEC in very preterm or very low birth weight infants, including growth-restricted infants. Delaying the introduction of progressive enteral feeds results in a few days delay in establishing full enteral feeds but the clinical importance of this effect is unclear. The applicability of these findings to extremely preterm or extremely low birth weight is uncertain. Further randomized controlled trials in this population may be warranted.”

Morgan J, Young L, McGuire W. Delayed introduction of progressive enteral feeds to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2013 May 31;5:CD001970. doi: 10.1002/14651858.CD001970.pub4

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Page 24: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

A.S.P.E.N. Clinical Guidelines: Nutrition Support of Neonatal Patients at Risk for

Necrotizing Enterocolitis

Recommendation: Minimal enteral nutrition be initiated within the first 2 days of life and advanced by 30 mL/kg/d in infants ≥1000 g.

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Page 25: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Patent Ductus Arteriosus (PDA)

•May not be as dangerous as previously thought –Bellander M, Ley D, Polberger S, Hellstrom-Westas L. Tolerance to early human milk feeding is not compromised by indomethacin in preterm infants with persistent ductus arteriosus. Acta Paediatr 2003;92:1074-8.

–Clyman R, et. al. Enteral Feeding during Indomethacin and Ibuprofen Treatment of a Patent Ductus Arteriosus. J Pediatr 2013.

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Page 26: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Umbilical Artery Catheter (UAC)

•The following studies gave small enteral feeds while infant had UAC line and found a DECREASE in the incidence of NEC

–Dunn 1988, Schanler 1999, Davey 1994

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Page 27: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Use of a Feeding Bundle Appears to Reduce Central Line

Utilization in Neonates

•Once an infant tolerates a minimum of 120 ml/kg/day of enteral feeds, the bundle recommends that the central line be removed.

•Central line utilization decreased in all groups (all p<0.001): –0.45 to 0.28 in ≤750g infants –0.4 to 0.27 in 751-1000g infants –0.39 to 0.3 in 1001-1500g infants

•The CLABSIs rate was unchanged • Implementation of a feeding bundle decreased central line

utilization

Tauber KA; et. al. JPGN; 2015

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Page 28: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Late Enteral Feedings Are Associated with Intestinal Inflammation and Adverse

Neonatal Outcomes

•A delay in enteral feedings after the third postnatal day is associated with:

–4.5 fold increase in chronic lung disease (95% CI 1.8-11.5, p=0.002)

–2.9 fold increase in retinopathy of prematurity (1.1-7.8, p=0.03) –3.4 fold increase in multiple comorbidities (1.2-9.8, p=0.02)

compared to infants fed on or before the third day.

•Additionally, a delay in the initiation of feedings is associated with increased fecal IL-8 levels and a decreased IL-10:IL-8 ratio.

Konnikova Y, Zaman MM, Makda M, D’Onofrio D, Freedman SD, Martin CR (2015) Late Enteral Feedings Are Associated with Intestinal Inflammation and Adverse Neonatal Outcomes. PLoS ONE 10(7): e0132924. doi:10.1371/journal.pone.0132924

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Page 29: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

“Slow” vs. “Fast” Advance

•Gestational Age <32 weeks at birth •Birth weight < 1,500 g

–“Slow” 2006/2007 (n = 136)

Enteral feeds were initiated on day 1 with 10–15 ml/kg/day and advanced by 15–20 ml/kg/day

–“Fast” 2010 (n = 88) Enteral feeds were initiated with 20 ml/kg/day on day 1 and advanced by 25–30 ml/kg/day The new approach was associated with a significantly shorter period to establish full enteral feeds.

Maas C, et. al. A Historic Cohort Study on Accelerated Advancement of Enteral Feeding Volumes in Very Premature Infants. Neonatology 2013;103:67–73.

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“Slow” vs. “Fast” Advance

•5 randomised controlled trials => total of 588 infants •Daily Advance: “Slow” = ^15 to 20 ml/kg “Fast” = ^30 to 35

ml/kg •Meta-analyses did not detect statistically significant effects on

the risk of necrotising enterocolitis (typical risk ratio (RR) 0.97, 95% confidence interval (CI) 0.54 to 1.74) or all-cause mortality (RR 1.41, 95% CI 0.81 to 2.74).

• Infants who had slow advancement took significantly longer to regain birth weight (reported median differences two to six days) and to establish full enteral feeding (two to five days).

Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2013 Mar 28;3:CD001241. doi: 10.1002/14651858.CD001241.pub4

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Page 31: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Standardized Slow Enteral Feeding Protocol and the Incidence of Necrotizing

Enterocolitis in Extremely Low Birth Weight Infants

Conclusion: “An SSEF protocol significantly reduces the incidence of NEC and combined NEC/death in infants with birth weight <750 g. Despite taking longer to achieve full enteral feeding on this protocol, surviving ELBW infants demonstrated comparable weight gain at discharge without prolonging their hospital stay.”

JPEN. 2015;39:644-654

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“High Residuals”

Common Physiologic “Excessive” gastric residuals, nor color differences (green, milky, or clear) in gastric residuals were shown to predict feeding tolerance.

Ziegler 1999, Mihatsch 2002, Moody 2000

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Clinical Experience

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Page 34: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Improved outcomes with a

standardized feeding protocol

for very low birth weight infants

McCallie KR, Lee HC, Mayer O, Cohen RS, Hintz SR, Rhine WD. Improved outcomes with a standardized feeding protocol for very low birth weight infants. J Perinatol. 2011;31(Suppl. 1):S61–7. doi: 10.1038/jp.2010.185.

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Page 35: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Total Subjects BW ≤ 1500 g

Inborn or transferred DOL 1-3 N=189

Before Feeding Protocol 7/1/06-3/31/07

N=96

After Feeding Protocol 4/1/07-12/31/07

N=93

Excluded N=3

Congenital heart disease (2),

oropharyngeal atresia

Excluded N=5

Congenital heart disease, omphalocele, tracheo-esophageal fistula, meconium

plugging, aqueductal stenosis

Incomplete data N=7

Hospital transfer (7)

Incomplete data N=12

Hospital transfer (9), missing flowsheets/orders (3)

Died before fed N=3

RDS, RDS+Infection, Prematurity+IVH

Died before fed N=12

Prematurity (3), Severe IVH (3), RDS, RDS+Severe IVH, RDS+Infection , RDS+Pulmonary hemorrhage ,

Sepsis/Infection, Pulmonary hypoplasia

Final Before Group Received enteral feeds

N=83 BW ≤ 1000 g = 31

BW 1001-1500 g = 52

Final After Group Received enteral feeds

N=64 BW ≤ 1000 g = 26

BW 1001-1500 g = 38

McCallie KR, et al. Improved outcomes with a standardized feeding protocol for very low birth weight infants. J Perinatol. 2011 Apr;31 Suppl 1:S61-7.

Study Flow

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Nutrition Outcomes Before and After Implementation of a Standardized

Feeding Protocol

DOL=day of life TPN=total parenteral nutrition.

McCallie KR, et al. 2011

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Page 37: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

DOL=day of life TPN=total parenteral nutrition.

McCallie KR, et al. 2011

* p = 0.02

** p = 0.01

Nutrition Outcomes Before and After Implementation of a Standardized

Feeding Protocol

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NEC Rates

* p = 0.01 ** p = 0.005

McCallie KR, et al. 2011

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* p = 0.01 ** p = 0.001

McCallie KR, et al. 2011

Late Onset Sepsis

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Page 40: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Average Daily Enteral Feeding Volumes During the 1st 28 Days of Life Before &

After Implementation of a Standardized Feeding Protocol for VLBW Infants

McCallie KR, et al. 2011

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Where to Start?

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Steps to Create a Feeding Pathway

1. Establish Criteria a. All infants < 1250 gm, or < 1000 gm? b. APGAR scores? c. SGA? d. Absent End Diastolic Flow? e. Exclusions include: Gastroschisis, Omphalocele,

Bowel Obstruction, Imperforate Anus, Malrotation, Volvulus

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Steps to Create a Feeding Pathway

2. Human Milk Availability a. Maternal breast milk b. Banked breast milk

i. Use until mom’s own milk is available ii. Use if mom’s own milk is unsafe to feed

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Steps to Create a Feeding Pathway

3. Volume a. Initiation b. 10-20 mL/kg/day for 3-5 days c. Advance d. Daily? Every other day? e. 10-30 mL/kg/day

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Page 45: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Steps to Create a Feeding Pathway

4. Write in breast milk fortification, as part of the feeding protocol

a. Volume to start i. 40 mL/kg/day? 60 mL/kg/day?

100 mL/kg/day? b. Product to start

i. Human Milk based vs. Bovine based

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Steps to Create a Feeding Pathway

5. Implement as an Automatic Order Set a. On admission b. At 24 hours of life c. Within 72 hours of life d. Other criteria/per provider

discretion

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Steps to Create a Feeding Pathway

6. Establish stopping criteria and guidelines a. Emesis b. Distended Abdomen c. Residuals? d. Other?

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Evaluate the Feeding Pathway

Give it time What works? What does not work?

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Page 49: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

Identifying Barriers to Initiating Minimal Enteral Feedings in Very Low-Birth-Weight

Infants: A Mixed Methods Approach

American Journal of Perinatology; 2015 DOI http://dx.doi.org/ 10.1055/s-0035-1556756.

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Feeding Protocol Summary

•Benefits: Patient, Family, Hospital

•ANY pathway is better than NO pathway

•Each baby needs to be closely monitored, evaluated and *may* need alterations to his/her feeding advancement

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Thank You

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Page 52: © 2015 Prolacta Bioscience · Early Enteral Feeding in . Very Low Birth Weight Infants •603 VLBW infants •Median time of feed initiation decreased from 33 to 14 h (p < 0.0001)

About Prolacta Bioscience® Prolacta develops clinically proven, high-value products derived from human milk that are designed to meet the needs of extremely premature infants in the Neonatal Intensive Care Unit.

[email protected]

www.prolacta.com

© 2015 Prolacta Bioscience


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