oral therapy and care for neonates

... Protocol Driven Solutions

Petite Swabs& Oral Care Kits

®Plak-Vac

Oral Therapy and The Use of Mother’s Milk

in the Treatment of Neonates

Clinical Update

Oral Therapy

Oropharyngeal Administration of

Colostrum

Oropharyngeal Administration of

Mother’s MilkOral

Hygiene

Developmental Support

Exposure to Immune System Agents

Infection Prevention

Expected Benefits

Shorter length of stay

Expected OutcomesReduced time to oral feeds

Fewer infections

Lower cost of care

Reduced time to enteral feeds

Healthy oral tissue

Seed the oral cavity with sIgA, interleukins lactoferrin, lysozyme and oligosaccharides.

Introduce taste & smell of mother’s milk toencourage maternal bonding, development of non-nutritive sucking, and calming/soothing.

Regular cleaning and moisturizing help reduce the possibility of healthcare-acquired infection and maintain good oral tissue health.

NPO and Tube Fed Babies

Extremely/Very Low Birthweight Babies

All Babies/Babies on Respiratory Support

Breast milk has been shown to confer a variety of immunological, health and developmental benefits to orally fed babies, including improving outcomes such as decreased HAI, incidence of necrotizing enterocolitis, length of stay, and infant neurodevelopment.(1) Unfortunately, clinical instability in ELBW and VLBW precludes feeds, and these babies do not enjoy the benefits of colostrum or mother’s milk until feeds begin, which given the standard clinical practice of delaying feeding for up to 8 weeks in the ELBW baby, increases the risk of intestinal atrophy and necrotizing enterocolitis.(2,3,4)

Recent clinical work by Rodriguez,(2,3,4) Seigel,(5) and Montgomery(6) suggest there may be meaningful benefits from the oropharyngeal administration of colostrum to very- and extremely-low-birth weight babies. It is thought that immune factors, which are at the highest levels in colostrum, may be absorbed by the mucous membranes, interact with and stimulate immune tissue in the oral cavity, and provide local barrier protection against pathogens.(2,3,4) Additionally, healthy bacteria found in mother’s milk may have a probiotic effect: the oral cavity of neonates lacks endogenous microbial flora, and the beneficial bacteria from milk can “seed” the oral cavity and provide additional protection against oral pathogens.(1,7)

A recent randomized controlled trial in extremely low birth weight babies found that there was a statistically significant reduction (10 days) in the time to reach full enteral feedings for babies receiving oropharyngeal administration of mother’s colostrum.(2,3,4)

1. Thibeau, S. et al., Exploring the Use of Mothers’ Own Milk as Oral Care for Mechanically Ventilated Very Low-Birth-Weight Preterm Infants. Advances in Neonatal Care Vol 13, No. 3, pp. 190-197.2. Rodriguez, N. et al A Randomized Controlled Trial of Oropharyngeal Administration of Mother’s Colostrum to Extremely Low Birthweight Infants in the First Days of Life. Neonatal Intensive Care Vol 24 No. 4 July-August 2011.3. Rodriguez, N. et al. A Pilot Study to Determine the Safety and Feasibility of Oropharyngeal Administration of Own Mother’s Colostrum to Extremely Low-Birth-Weight Infants. Advances in Neonatal Care Vol. 10, No. 4 pp. 206-2124. Rodriguez, N. et al. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 January; 29(1): 1-7.5. Siegel, J. et al. Early Administration of Oropharyngeal Colostrum to Extremely Low Birth Weight Infants. Breastfeeding Medicine Volume 8, Number 0, 2013.6. Montgomery, D.P. et al. Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants: Results of a Feasibility Study. Neonatal Intensive Care Vol 23, No. 1 January-February 2010. 7. Brady, T. Health care-associated infections in the neonatal intensive care unit. American Journal of Critical Care, 2005; 33:268-275.8. Hylander MA et al. Human Milk Feedings and Infection Among Very Low Birth Weight Infants. Pediatrics 1998;102(3).

Complex carbohydrate molecules that inhibit the adhesion of pathogens on the epithelial surface and interact with immune cells.(2,3,4)

Immune Factor Mechanism of Action

Secretory Immunoglobulin A (sIgA) Inhibits attachment of pathogens to respiratory and intestinal mucosal tissue.(2,3,4)

Interleukin-6Interleukin-10

Immunomodulators that may stimulate sIgA production in the lymphoid cells of the oral cavity.(2,3,4)

Lactoferrin Iron-binding protein with antimicrobial and antiviral properties.(2,3,4)

Lysozyme Enzyme that attacks and damages the cell wall of bacteria, especially gram-positive bacteria.(8)

Human Milk Oligosaccharides

Direct absorption of immunologic agents throughthe oral mucosa.

Faster time to full enteral feeds- 10 days sooner andshorter length of stay.

Objective

Potential Clinical Outcomes

Oropharyngeal Administration of Colostrumin Extremely and Very Low Birthweight NPO Babies

Exposure to immunologic agents including:sIgA, interleukins, lactoferrin, lysozyme, andoligosaccharides.

Application of colostrum directly to the orpharnygeal mucosa.

Treatment

Expected Clinical Benefits

449 Sovereign Court

St. Louis, MO 63011

Phone: 636-527-2288

Disclaimer: This information is provided by Trademark Medical as an informational service, and is not intended to substitute for professional medical judgment in the treatment of patients, nor does this information in any wayinfer the marketing or sale of Trademark Medical products beyond the limitations of FDA regulation. M1024B

Developmental Care Benefits: Taste and Smell

The taste and smell of mother's milk helps babies identify their mother and creates an important bond between mother and baby. Additionally, exposure to the taste and smell of mother’s milk may facilitate the development of feeding skills and produce a calming effect on the baby.

Babies “respond positively” to the taste and smell of mother’s milk, and exposure to mother’s milk facilitates recogni-tion of the mother.(1) Babies not orally fed (ie, NPO, ventilated, tube feeders) do not have the opportunity to develop a taste for mother’s milk, which could potentially contribute to oral aversion and delayed development of feeding skills. One study notes that babies who had the oral mucosa swabbed with colostrum “appeared to taste” the colostrum as noted by sucking on the breathing tube.(3,5) This non-nutritive sucking can produce an analgesic and calming effect,(6) and may help in the transition from tube feeding to bottle feeding.(7)

Improved Clinical Outcomes

Evidence suggests the application of mother’s milk to the oral cavity could improve clinical outcomes. In naso- and oro-gastrically fed infants, the taste and smell of mother’s milk was shown to increase intake, weight gain, and growth, and shorten the length of hospitalization by 4 days.(1,8) Preterm infants exposed to breast milk odor during gavage feeding made the transition to oral feeding 3 days sooner,(8) and pilot studies have shown a reduction in the time to beginning full enteral feeds.(2,3)

1.Browne, J Chemosensory Development in the Fetus and Newborn. Newborn & Infant Nursing Reviews, December 2008 Vol 8, Number 4 www.nainr.com2.Rodriguez, N. et al A Randomized Controlled Trial of Oropharyngeal Administration of Mother’s Colostrum to Extremely Low Birthweight Infants in the First Days of Life. Neonatal Intensive Care Vol 24 No. 4 July-August 2011.3.Rodriguez, N. et al. A Pilot Study to Determine the Safety and Feasibility of Oropharyngeal Administration of Own Mother’s Colostrum to Extremely Low-Birth-Weight Infants. Advances in Neonatal Care Vol. 10, No. 4 pp. 206-2124.Rodriguez, N. et al. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 January; 29(1): 1-7.5.Thibeau, S. et al., Exploring the Use of Mothers’ Own Milk as Oral Care for Mechanically Ventilated Very Low-Birth-Weight Preterm Infants. Advances in Neonatal Care Vol 13, No. 3, pp. 190-197.6.Bingham, P et al. A Pilot Study of Milk Odor Effect on Nonnutritive Sucking by Premature Newborns. Arch Pediatr Adolesc Med/ Vol 157, Jan 20037.Raimbault, C. et al, The effect of the doour of mother’s milk on breastfeeding behaviour of premature neonates. Acta Paediatrica 2007 96, pp 368-371.8.Yildiz, A. The Effect of the Odor of Breast Milk on the Time Needed for Transition From Gavage to Total Oral Feeding in Preterm Infants. Journal Nursing Scholarship, 2011: 43:3, 265-273

Enhance Maternal Bonding(1)

StimulateNon-Nutritive Sucking(4)

Mitigate Oral Aversion(4)

Calm and Soothe Baby(1)

Faster Transitionto Oral Feeding(8)

Faster Transitionto Enteral Feeding(4)

Shorter Length of Hospitalization(8)

DevelopmentalBenefits

PotentialOutcomes

Potential Benefits of Mother’s Milk as Oral Therapy

� � � �

� � �

Oropharyngeal Administration of Mother’s Milkin NPO and Tube Fed Babies

Introduce taste and smell of mother/mother’s milk to babies that are not feeding orally.

Encourage maternal bonding, development of non-nutritive sucking, and calming/soothing.

Application of mother’s milk directly to the orpharnygeal mucosa.

Treatment Objective

Potential Clinical OutcomesShorten time to full oral feeds- 3 days sooner,reduce length of stay- 4 days, and possibly reduce oral aversion.

Expected Clinical Benefits

449 Sovereign Court

St. Louis, MO 63011

Phone: 636-527-2288

Disclaimer: This information is provided by Trademark Medical as an informational service, and is not intended to substitute for professional medical judgment in the treatment of patients, nor does this information in any wayinfer the marketing or sale of Trademark Medical products beyond the limitations of FDA regulation. M1025B

Babies are unable to provide their own oral care or communicate oral discomfort or needs, therefore oral care must be provided by a caregiver. Poor oral hygiene can lead to excessive bioburden in the oral cavity, resulting in the deterioration of oral tissue health, and the potential for aspiration of highly virulent secretions. Healthy oral tissue helps maintain integrity of the oral cavity’s natural immunological capabilities,(1) therefore, it is desirable to preserve healthy oral tissue to help prevent systemic disease.

In light of these factors, the CDC suggests that health care facilities develop and implement a comprehensive oral hygiene program for patients in all acute care settings, including those in the neonatal intensive care unit (2), and the IHI recommends “comprehensive mouthcare appropriate to the age of the patient” as part of their Pediatric Ventilator-Associated Pneumonia (VAP) Change Package.(3) These recommendations have been implemented by the vast majority of adult ICU’s, as well as many PICU’s, with formal oral care protocols defining a standard of care for these patient populations.

Neonates can also benefit from the development of standardized oral care protocols. Newborns have unique characteristics which predispose them to infection, including 1) an immature immune system with abnormal granulo-cyte migration and bacterial digestion, decreased activity of complement, particularly complement opsonization and low immunoglobulin G (IgG) levels,(4) 2) permeable skin and mucus membranes,(1,5) 3) a lack of endogenous micro-bial flora (1,5) and 4) frequent blood draws that decrease levels of immunological agents.(1) These factors create the possibility that oral flora may not develop “normally” in NICU babies, and initial colonization may include potentially harmful bacteria present in the NICU, e.g., K. pneumoniae, E. coli, P. aeruginosa, and S. aureus,(1,6,7) possibly leading to healthcare acquired infection and deterioration of oral tissue.

1. Brady, T. Health care-associated infections in the neonatal intensive care unit. American Journal of Critical Care, 2005; 33:268-275.2. Garland, L.S. (2010). Strategies to prevent ventilator-associated pneumonia in neonates. Clinics in Perinatology, 37, 629-643.3. http://www.ihi.org/knowledge/Pages/Tools/HowtoGuidePreventVAPPediatricSupplement.aspx.4. Foglia, E., Meier, M.D., & Elward, A. (2007). Ventilator-associated pneumonia in neonatal and pediatric intensive care unit patients. Clinical Microbiology Reviews, 20(3), 409-425.5. Donowitz,G., Nosocomial infection in neonatal intensive care units. Am J Infect Control 1989;17:250-76. Makhoul, I et al. Factors influencing oral colonization in premature infants. IMAJ 2002;4:98-1027. Goldmann, D et al. Bacterial colonization of neonates admitted to an intensive care environment. Journal of Pediatrics 1978;2:288-293.8. Stefanescu, B. et al., A Pilot Study of Biotene OralBalance Gel for Oral Care in Mechanically Ventilated Perterm Neonates. Contemporary Clinical Trials 35 (2013) 33-399. Schooley, K., et al., Quality Improvement Project: Decreasing Ventilator Associated Pneumonia Rate in our NICU at Overland Park Regional Medical Center. Vermont Oxford Network. http://www.vtoxford.org/meetings/AMQC/Handouts2012/LearningFair/OverlandParkRegional_DecreasingVentilationAssociatedPneumonia.pdf10. Ceballos, K. et al., Nurse-Driven Quality Improvement Interventions to Reduce Hospital-Acquired Infection in the NICU. Advances in Neonatal Care 2013 Vol 13, No. 3 pp 154-163.11.http://www.ihi.org/offerings/MembershipsNetworks/MentorHospitalRegistry/Documents/Central%20DuPage%20-Creating%20and%20Implementing%20a%20Bundle%20to%20Reduce%20VAP%20in%20the%20 NICU%202011.pdf12. Wilson, S. et al Oral Care in the Neonate: One Step in a Bundle To Reduce Ventilator Associated Pneumonia (VAP). Pediatric Academic Societies Poster Session E-PAS2012:1519.349.

Bacterial colonization of the oral cavity was reduced by 54%, and gram negative colonization was eliminated in 33% of affected patients in a pilot study utilizing a q6 oral care regimen with water or mother’s milk.(12)

VAP rates were reduced to zero after implementation of a bundle including a q3-4 oral care protocol using mother’s milk, Biotene OralBalance Gel or sterile water. (11)

VAP rates declined 71% in a study utilizing a q3-4 oral care protocol with mother’s milk or sterile water as part of a ventilator bundle. (10)

VAP rates declined after the implementation of a VAP bundle including a q4 oral care protocol using mother’s milk or sterile water. (9)

Oral Hygienefor All Babies and Babies on Respiratory Support

Reduce bioburden in the oral cavity, stimulate oral tissue, and minimize drying of oral tissue lips and nares.

Clean and moisturize the oral cavity of all babies,and particularly those on respiratory support- ie., ventilators, CPAP.

Reduce the possibiliity of healthcare acquired infection and maintain good oral tissue health.

Prevent ventilator-associated and hospital acquiredpneumonias, minimize potential for systemic infection and oral lesions.

Treatment Objective

Potential Clinical OutcomesExpected Clinical Benefits

Potential Benefits of a Standardized Oral Hygiene Regimen

449 Sovereign Court

St. Louis, MO 63011

Phone: 636-527-2288

Disclaimer: This information is provided by Trademark Medical as an informational service, and is not intended to substitute for professional medical judgment in the treatment of patients, nor does this information in any wayinfer the marketing or sale of Trademark Medical products beyond the limitations of FDA regulation. M1026A

The Potential Impact of Oral TherapyImproved Clinical Outcomes

Lower Costs and Other Benefits

Healthy Oral Tissue

1. Rodriguez, N. et al A Randomized Controlled Trial of Oropharyngeal Administration of Mother’s Colostrum to Extremely Low Birthweight Infants in the First Days of Life. Neonatal Intensive Care Vol 24 No. 4 July-August 2011.2. Yildiz, A. The Effect of the Odor of Breast Milk on the Time Needed for Transition From Gavage to Total Oral Feeding in Preterm Infants. Journal Nursing Scholarship, 2011: 43:3, 265-273.3. Wilson, S. et al Oral Care in the Neonate: One Step in a Bundle To Reduce Ventilator Associated Pneumonia (VAP). Pediatric Academic Societies Poster Session E-PAS2012:1519.349.4. Ceballos, K. et al., Nurse-Driven Quality Improvement Interventions to Reduce Hospital-Acquired Infection in the NICU. Advances in Neonatal Care 2013 Vol 13, No. 3 pp 154-163.5. Russell, B et al., Cost of Hospitalization for Preterm and Low Birthweight Infants in the United States. Pediatrics 2007;Volume 120, Number 1 July 2007:e1-e9.

Day

s

Day

s

Length of Stay Enteral Feeds0

5

10

15

20

25

A 3 day reduction in time to full oral feeds and a 4 day reduction in length of stay was shown in tube fed babies exposed to the smell of mother’s milk.(2)

Treatment Group

Control Group

Reduced Time to Oral Feeds & Shorter Length of Stay

VAP rates declined 71% in a study utilizing a q3-4 oral care protocol with mother’s milk or sterile water as part of a ventilator bundle.(4)

Treatment Group

Control Group

Fewer Infections

A pilot study in very low birthweight babiesusing oropharyngeal administration of colostrum showed a 10 day reduction in time to enteral feeds.(1)

0

5

10

15

20

25

Treatment Group

Control Group

Reduced Time to Enteral Feeds

0

3

6

9

12

15

Bacterial colonization of the oral cavity was reduced by 54%, and gram negative colonization was eliminated in 33% of affected patients, in a pilot study utilizing a q6 oral care regimen with water or mother’s milk.(3)

Treatment Group

Control Group

Colonized Gram Negative

Pat

ient

s

VAP

Rat

e

0

5,000

10,000

15,000

20,000

25,000

30,000

$35,000

Lower Cost of Care

A 4 day reduction in length of stay, from 23 to 19 days,(2) yields a 17% cost savings based on a $1,500 average per day cost of treat-ment in the NICU(5)

$34,500

$28,500 } $6,000 Savings

In addition to direct cost savings, indirect benefits may accrue from a comprehensive oral therapy program:

Babies may be calmed and comforted by mother’s milk.

Maternal bonding is encouraged both by acclimating the baby to the mother’s smell, and by parental participation in oral therapy.

Non-nutritive sucking may be stimulated.

Oral aversion may be mitigated by introducing the taste of mother’s milk.

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Disclaimer: This information is provided by Trademark Medical as an informational service, and is not intended to substitute for professional medical judgment in the treatment of patients, nor does this information in any way infer the marketing or sale of Trademark Medical products beyond the limitations of FDA regulation.

*Lansinoh is a registered trademark of Lansinoh Laboratories, Inc. Alexandria VA *Ayr is a registered trademark of BF Ascher & Co, Inc, Lenexa KS *Little Sucker is a registered trademark of Neotech Products, Inc. Valencia, CA *Biotene is a registered trademark of GlaxoSmithKline LLC Wilmington DE *Bebeonker is a registered trademark of Small Beginnings, Inc. Hesperia, CA

Disclaimer: Trademark Medical makes no claim of safety or efficacy for any products used in Plak-Vac Oral Care Kits beyond those made by the product manufacturer’s legally approved claims and indications for use.

Made in U.S.A. M1023B

449 Sovereign Court

St. Louis, MO 63011

Web: www.trademarkmedical.com

Phone: 636-527-2288

Order Now:Call: 800-325-9044Fax: 636-527-0255

Plak-Vac Petite Swabs

®®®

IV Pole Hanger

Suction Catheters 8,10,12 Fr.Small Beginnings Bebeonkers*

Neotech Little Sucker*Preemie or Standardwith or without Cover

Sterile Water 5 mlBiotene* Oral Balance

Gel 3g

White Petrolatum 5gLansinoh* Lanolin

Ayr* Saline Gel 0.5 ozSaline Wipes Medicine Cup

2” x 2” Gauze

Sterile Saline 5 ml

Oral Suction & OptionsCleanser & Moisturizer Options

8 mmHead

6 mmHead

12 mmHead

(Actual) Size)

LAHead

Change kit on:

Mon Tues Wed Thur Fri Sat SunThis kit is intended for 24 hours of oral care. Single patient use.

Kit Contents:6 - Petite Applicator Swab – 6 mm6 - Petite Applicator Swab – 8 mm6 - Sterile Water – 5 ml

Order No.Lot No.

Contents are Non SterileExp Date:

St. Mary’s Medical Centerq4 Petite Oral Care Kit

Manufactured for:

St. Louis, MO 63011800-325-9044

Oral Care Procedure

¾ Use contents as directed by Oral Care Protocol to clean patient’s oral cavity.

Pouch Contents

Petite Swab 6 mmPetite Swab 8 mm

Sterile Water

Contents are Non-Sterile

04:00-06:00 Hours

Oral Care Procedure


Pouch Contents


Sterile Water


00:00-02:00 Hours

Oral Care Procedure


Pouch Contents


Sterile Water


20:00-22:00 Hours

Oral Care Procedure


Pouch Contents


Sterile Water


16:00-18:00 Hours

Oral Care Procedure


Pouch Contents


Sterile Water


12:00-14:00 Hours

Oral Care Procedure


Pouch Contents


Sterile Water


08:00-10:00 Hours

Kit Change Indicator

Timed Treatment Packets

Customer-Specified Protocol

Customized Contents

Plak-Vac Petite Daily Kits

Plak-Vac tailor-made daily kits organize all components at the point-of-care to enhance protocol compliance and support infection control policies. Choose from our size-appropriate Petite swabs and a variety of options for cleaning, moisturizing, and suctioning the oral cavity.

Plak-Vac® Petite products support all oral therapy needs

A New Standard of Oral Care for the NICU

449 Sovereign Court

St. Louis, MO 63011

Web: www.trademarkmedical.com

Phone: 636-527-2288

Made in U.S.A. M1027B

Order Now:Call: 800-325-9044Fax: 636-527-0255

Petite Low Absorption SwabPlak-Vac® Oral Care

Plak-Vac Petite LA Swab (actual size)

TM®

The Plak-Vac®

Petite LATM

low absorption swab was developed for applications where the loss

of oral therapy solution (e.g., colostrum) must be minimized. The Petite LA swab is size

appropriate for even the smallest babies and features a soft, non-shedding foam head that will

not lint or fray when wet, and a smooth polypropylene handle rather than wood.

0

20

40

60

80

100

% o

f 0

.2 m

l d

ose

Fluid Retained by SwabFluid Delivered

Cotton Tipped

Applicator

Plak-Vac

Petite LA Swab

Treatment Dose Application Swab Test Results

Due to it’s low absorption and

small head, the Petite LA swab is

ideal for applications such as the

oropharyngeal administration of

colostrum as described by

Rodriguez at al.*

The Petite LA swab can be

incorporated into a Plak-Vac oral

care kit to support an oropharyn-

geal colostrum administration

protocol, by combining the swab

with other components such as

a 1 cc syringe, gauze pads,

sterile water, gloves, and other

accessories.

Change kit on:

Mon Tues Wed Thur Fri Sat SunThis kit is intended for 24 hours of oral care. Single patient use.

Kit Contents:6 - Petite Applicator Swab – 6 mm

6 - Petite Applicator Swab – 8 mm

6 - Sterile Water – 5 ml

Order No.Lot No.

Contents are Non SterileExp Date:

St. Mary’s Medical Centerq4 Petite Oral Care Kit

Manufactured for:

St. Louis, MO 63011

800-325-9044

Oral Care Procedure

¾ Use contents as directed

by Oral Care Protocol to

clean patient’s oral cavity.

Pouch Contents

Petite Swab 6 mm

Petite Swab 8 mm

Sterile Water


04:00-06:00 Hours

Oral Care Procedure




Pouch Contents

Petite Swab 6 mm

Petite Swab 8 mm

Sterile Water


00:00-02:00 Hours

Oral Care Procedure




Pouch Contents

Petite Swab 6 mm

Petite Swab 8 mm

Sterile Water


20:00-22:00 Hours

Oral Care Procedure




Pouch Contents

Petite Swab 6 mm

Petite Swab 8 mm

Sterile Water


16:00-18:00 Hours

Oral Care Procedure




Pouch Contents

Petite Swab 6 mm

Petite Swab 8 mm

Sterile Water


12:00-14:00 Hours

Oral Care Procedure




Pouch Contents

Petite Swab 6 mm

Petite Swab 8 mm

Sterile Water


08:00-10:00 Hours

Kit Change Indicator

Timed Treatment Packets

Customer-Specified Protocol

Customized Contents

Plak-Vac Oral Care Kits

* Rodriguez, N. et al. A Pilot Study to Determine the Safety and Feasibility of Oropharyngeal Administration of Own Mother’s Colostrum to Extremely Low-Birth-Weight

Infants. Advances in Neonatal Care Vol. 10, No. 4 pp. 206-212

The Petite LA swab retains roughly half

of the fluid a cotton tipped applicator

absorbs- conserving the oral therapy

solution for delivery to the patient rather

than being thrown away with the swab.

Disclaimer: Trademark Medical makes no claim of safety or efficacy for any products used in Plak-Vac Oral Care Kits beyond those made by the product manufacturer’s legally approved claims and indications for use.