Principal investigator: Dominique Fons, MDHolly Kapraun, DOShane Rainey, DOSeth Van Heukelom, DOKari Beth Watts, DO

Evaluate whether utilizing OMT as an adjunct to lactation support will improve feeding outcomes

Hypothesis: In term newborns with feeding dysfunction, OMT in addition to lactation support will improve feeding outcomes.

Osteopathic manipulative treatment Form of manual medicine created by Andrew Taylor Still, MD, DO

in late 19th century Techniques range from soft tissue massage to high-velocity/low-

amplitude manipulation Designed to treat both somatic and visceral dysfunction across all

organ systems

Nipple feeding requires coordinated suck and swallow

Dependent on cranial nerves IX, X, XII

36-88% of newborns with cranial dysfunction

Photo credit: http://teachmeanatomy.info/wp-content/uploads/CN-base-of-skull.jpg

Studies limited by small size Premature twins with feeding dysfunction who improved with addition

of OMT (Lund 2010) Six breastfed infants with feeding dysfunction who improved with

addition of OMT (Fraval 1998)

Single-blinded RCT similar to our protocol found single OMT session improved feeding outcomes (Herzhaft-Le Roy et al 2016) Other studied benefits of OMT on newborns: Decreased GI symptoms in neonates Decreased NICU length of stay

Type: Single-blinded, randomized controlled, prospective study. Parents, lactation consultants & nursing staff are blinded. Location: UnityPoint Health - Methodist Enrollment: Open to all newborns born at

UPH-M who meet criteria from Monday to Thursday each week. Randomization: Alternating assignments

from alphabetical list.

Term Infants greater than or equal to 37 weeks gestation Level I newborn Receiving lactation support Identified by lactation as having a newborn component to feeding

dysfunction Admitted to UnityPoint Health Methodist hospital Available for at least 2 inpatient treatment sessions Informed Consent

Infants <37 weeks of gestation Level II or III newborns Infants who are wards of the state Term infants who are receiving speech therapy or physical

therapy Infants already receiving OMT Infants who are not breastfeeding Infants who have a feeding dysfunction mostly attributed to

maternal factors

Treatment Group

Condylar DecompressionCervical Still

Technique Balancing of Hyoid

BoneMyofascial Release of

Thoracic Inlet

Control Group

“Sham” OMTDiagnose but provide

no corrective treatment

Photo credit: www.survivinggrays.com/wp-content/uploads/2013/06/omt-newborn.jpg

Photo credit: http://jaoa.org/data/Journals/JAOA/932139/102fig8.jpeg

Designed and validated by Jensen et. al. (1994) Latch Audible swallowing Type of nipple (this aspect of data will not be used in study) Comfort of mother Help mother needs holding infant to breast

Demonstrated reliability Higher scores predictive of longer breastfeeding duration and

maternal satisfaction 2 points per component

Lactation consultants and nursery RNs trained to assess and assign LATCH scoreCharting score in EPIC is already a part of their

workflow Lactation/RN assign LATCH score with each observed

breastfeeding session

OMT providers add progress note on charts of all participants indicating enrollment but NOT disclosing assignment

Procedure documentation completed on paper and scanned to “Media” tab of EPIC approximately 2 weeks after participant’s discharge.

Total number of enrollees to date(December 2017 – Present)

8

Number of enrollees excluded 4

- 3 stopped breastfeeding- 1 transferred to NICU

Number of enrollees remaining 4- 3 sham treatments- 1 OMT treatment

Number of enrollees fed exclusively at breast 0- 2 babies bottlefed formula on few

occasions- 1 baby bottlefed donor breast milk on few

occasions- 1 baby with tube/syringe feeds of

maternal breast milk

Pre #1 Pre #2 Pre #3 Pre #4 Pre #5 Average

Sham #1 3 4 4 8 8 5.4

Sham #2 4 5 4 6 5 4.8

Sham #3 6 5 4 0 5 4.6

OMT 3 0 7 0 4 2.8

Post #1 Post #2 Post #3 Post #4 Post #5 Average

Sham #1 5 7 7 5 6 6.0

Sham #2 7 5 7 4 n/a 5.75

Sham #3 6 6 7 n/a n/a 6.33

OMT 8 8 6 6 n/a 7.0

0

1

2

3

4

5

6

7

8

Pre-Tx Post-TxSham #1 Sham #2 Sham #3 OMT

0

1

2

3

4

5

6

7

8

Pre-Tx Post-Tx

Sham Avg OMT

Randomized, single blindedReproducible with treatment protocol Low-risk Cost-effectiveWelcomed by parents/families

Lack of workflow with lactation consultantsVariety of lactation interventionsDifferent staff assigning LATCH scoresNot diagnosing/treating specific dysfunction, Inadvertent treatment with “sham”Low inpatient breastfeeding rate

Improve enrollment workflowNeed about 80 patients per arm for adequate powerDrs. Watts and Kapraun will continue involvement in

the study over the next 1-2 yearsConsider expanding across other hospitals in the

future

Centers for Disease Control. Breastfeeding: Why it Matters. Available at https://www.cdc.gov/breastfeeding/about-breastfeeding/why-it-matters.html. Accessed 10 May 2018.

Pizzolorusso G, Cerritelli F, D'Orazio M, et al. Osteopathic evaluation of somatic dysfunction and craniosacral strain pattern among preterm and term newborns. J Am Osteopath Assoc. 2013;113(6):462-467.

Frymann V. The collected papers of Viola Frymann, DO. Legacy of Osteopathy to Children (Bourgeois M; Turcotte C; Trans). Montreal, Quebec: Spirales Ed.

Pizzolorusso G, Turi P, Barlafante G, et al. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: Anexploratory study. Chiropr Man Therap. 2011;19(1):15-709X-19-15.

Pizzolorusso G, Cerritelli F, Accorsi A, et al. The effect of optimally timed osteopathic manipulative treatment on length of hospital stay in moderate and late preterm infants: Results from a RCT. Evid Based Complement Alternat Med. 2014;2014:243539.

Lund GC, Edwards G, Medlin B, Keller D, Beck B, Carreiro JE. Osteopathic manipulative treatment for the treatment of hospitalized premature infants with nipple feeding dysfunction. J Am Osteopath Assoc. 2011;111(1):44-48.

Fraval M. A pilot study: osteopathic treatment of infants with sucking dysfunction. Am Acad Osteopath J. 1998; 8 (2): 25-33.

Herzhaft-Le Roy J, Xhignesse M, Gaboury I. Efficacy of an osteopathic treatment coupled with lactation consultations for infants' biomechanical sucking difficulties. J Hum Lact. 2017;33(1):165-172

Jensen D, Wallace S, Kelsey, P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994; 23 (1): 27-32.

Altuntas N, Turkyilmaz C, Yildiz H, et al. Validity and reliability of the infant breastfeeding assessment tool, the mother baby assessment tool, and the LATCH scoring system. Breastfeed Med. 2014;9(4):191-195.

Riordan J, Bibb D, Miller M, Rawlins T. Predicting breastfeeding duration using the LATCH breastfeeding assessment tool. J Hum Lact. 2001;17(1):20-23.

Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006;22(4):391-397.

UnityPoint Heath – Methodist Perinatal Interdisciplinary Team. Meeting Minutes: 9 Apr 2017.

Centers for Disease Control. Breastfeeding Report Card, 2016. Available at https://www.cdc.gov/breastfeeding/data/reportcard.htm. Accessed 15 May 2018.