Osteopathic Manipulation in Breastfed Newborns

NCT03945474 | Unknown

• 1 other identifier: 986099
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Osteopathic manipulative treatment(OMT) is a form of manual medicine in which a trained physician uses his or her hands to diagnose areas of restriction in a patient's body. The physician then uses his or her hands to manually correct the restriction, to improve body function. The research team will be performing OMT on breastfed newborns that have been identified by lactation consultants as having a feeding issues. The team will then compare the feeding behaviors of these babies to those in the same category who did not receive OMT. OMT has some similarities to chiropractic manipulation. No thrusting techniques that produce a popping or cracking sound, as traditionally associated with chiropractic, will be used in this study. Infants will be assigned to either the OMT group or No OMT group by the research team using a randomized process to help ensure equal enrollment in both groups. All babies will receive standard lactation support. All newborns receiving OMT will undergo the same four treatments, all of which involve light touch and massage. All newborns not receiving OMT will undergo a gentle application of light touch but no treatment. OMT treatment or sham sessions will be brief, taking no longer than 10 minutes, with each infant receiving two sessions during the study. During breastfeeding sessions, a lactation consultant will assess the infant's breastfeeding behavior using a tool called the LATCH score. He/she will be scored upon enrolling in the study, daily during hospitalization and before discharge from the hospital. The breastfeeding scores of the newborns who received OMT will be compared to the scores of those who did not. The following is information regarding the types of treatment the investigators will use in the study:All treatments will be done with the baby lying on his or her back and will be gentle, applying no more force than would be used to test a tomato for ripeness. The provider's touch will be delicate enough so as not to blanch his or her fingernail beds while treating the infant. The first technique will reduce tightness in the sternocleidomastoid muscle, a front neck muscle that bends the head to one side and rotates the head the opposite side. The second technique treatment is used to correct tightness at the occipital condyle, which is the joint formed by the bone at the base of the skull and the top vertebrae of the neck. The hyoid bone is located in the neck and it aids in tongue movement and swallowing. The practitioner will apply gentle motion to the hyoid bone, usually using a finger and thumb. In the last technique, the physician will apply gentle motion to the connective tissue circling the baby's upper chest, shoulders, upper back, and lower neck, typically using the thumb and a few fingers on each hand. The purpose of this study is to determine whether osteopathic manipulative treatment (OMT) as an adjunct to lactation support will improve outcomes in breastfed newborns with feeding dysfunction.

Conditions

Osteopathic Medicine; Breast Feeding

Outcome Measures

Primary Outcomes (2)

• Latch Score

  LATCH is a 10 point scale that attaches 2 points to 5 measures: L(latch): 0=too sleep, no latch, 1=repeated attempts, hold nipple in mouth, 2=grasps breast, tongue down, lips placement and sucking pattern. A(audible swallowing): 0=none, 1=a few with stimulation, 2=spontaneous and intermittent. T(type of nipple): excluded due to maternal factors. C(comfort of breast/nipple):0=engorged, cracked, bleeding, severe discomfort, 1=filling small blisters, mild-mod discomfort, 2= soft, tender. H(hold of infant): 0=full assist by staff, 1=minimal assist, teach one side and mother does other side, 2=no assistance, Mother positions and holds infant swallowing, comfort, hold. This study uses a subscale without the T(nipple type). The total range of the LATCH scores will be 0-8, with 8 being the highest score, indicating successful breastfeeding. A score of 0 indicates poor breastfeeding.

  Every feeding from birth until first treatment, up to 3 days of life

• Latch Score

  LATCH is a 10 point scale that attaches 2 points to 5 measures: L(latch): 0=too sleep, no latch, 1=repeated attempts, hold nipple in mouth, 2=grasps breast, tongue down, lips placement and sucking pattern. A(audible swallowing): 0=none, 1=a few with stimulation, 2=spontaneous and intermittent. T(type of nipple): excluded due to maternal factors. C(comfort of breast/nipple):0=engorged, cracked, bleeding, severe discomfort, 1=filling small blisters, mild-mod discomfort, 2= soft, tender. H(hold of infant): 0=full assist by staff, 1=minimal assist, teach one side and mother does other side, 2=no assistance, Mother positions and holds infant swallowing, comfort, hold. This study uses a subscale without the T(nipple type). The total range of the LATCH scores will be 0-8, with 8 being the highest score, indicating successful breastfeeding. A score of 0 indicates poor breastfeeding.

  from OMT/Sham until discharge or followup with lactation(4 weeks of life)

Study Arms (2)

OMT

EXPERIMENTAL

Patients will receive a standardized protocol of: condylar decompression, Still's technique for the sternocleidomastoid, hyoid rebalancing and thoracic inlet myofascial release.

Other: Osteopathic Manipulation, OMT

Sham

SHAM COMPARATOR

Patient will be treated in the supine position, with hands gently applied without pressure to the four areas: occiput, lateral cervical spine, hyoid area and thoracic inlet.

Other: Sham

Interventions

Sham OTHER

See description in sham arm.

Sham

Osteopathic Manipulation, OMT OTHER

See description in OMT arm

OMT

Eligibility Criteria

• Age: 20 Hours - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• term infants \> 37 weeks gestation
• Level I newborn
• receiving lactation support
• identified by lactation as having a newborn component to feeding dysfunction, -must be available for at least two inpatient treatment sessions
• parent has provided informed assent.

You may not qualify if:

• infants \<37 weeks gestation
• Level II or III nursery status
• wards of the state
• receiving speech or physical therapy
• currently receiving OMT, bottlefed infants
• infants breastfeeding with maternal factors contributing to feeding dysfunction (e.g. nipple problem).

Sponsors & Collaborators

• Methodist Medical Center of Illinois: lead
• University of Illinois College of Medicine at Peoria: collaborator
• OSF Healthcare System: collaborator

Study Sites (2)

UnityPoint Methodist Peoria Medical Center

Peoria, Illinois, 61602, United States

RECRUITING

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

ACTIVE NOT RECRUITING

Related Publications (7)

• Pizzolorusso G, Cerritelli F, D'Orazio M, Cozzolino V, Turi P, Renzetti C, Barlafante G, D'Incecco C. Osteopathic evaluation of somatic dysfunction and craniosacral strain pattern among preterm and term newborns. J Am Osteopath Assoc. 2013 Jun;113(6):462-7.

  PMID: 23739757 BACKGROUND

• Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.

  PMID: 21711535 BACKGROUND

• Riordan J, Bibb D, Miller M, Rawlins T. Predicting breastfeeding duration using the LATCH breastfeeding assessment tool. J Hum Lact. 2001 Feb;17(1):20-3. doi: 10.1177/089033440101700105.

  PMID: 11847847 BACKGROUND

• 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 Feb;33(1):165-172. doi: 10.1177/0890334416679620. Epub 2016 Dec 27.

  PMID: 28027445 BACKGROUND

• Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.

  PMID: 17062784 BACKGROUND

• 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 Jan;111(1):44-8. doi: 10.7556/jaoa.2011.111.1.44.

  PMID: 21258016 BACKGROUND

• Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.

  PMID: 8176525 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

salicylhydroxamic acid; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Dominique K Fons, MD

  Methodist Medical Center of Illinois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique K Fons, MD

CONTACT

3096725908; Dominique.Fons@unitypoint.org

Kari B Watts, DO

CONTACT

3096725908; Kari.Watts@unitypoint.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Parents, infants and lactation consultants are not made aware of in which group the patient is placed, OMT or sham. Physicians are the only people aware of treatment/sham status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized to either arm, OMT or sham.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 10, 2019
• Study Start: October 10, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)