Recruiting

Osteopathic Manipulation

Sponsor:

Methodist Medical Center of Illinois

Code:

NCT03945474

Conditions

Osteopathic Medicine

Breast Feeding

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Sham

Osteopathic Manipulation, OMT

Study Details

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

Study ID

NCT03945474

Start date

Oct 10, 2017

Status verified date

May, 2019

Completion date

Oct 31, 2019

Anticipated

Primary completion date

Oct 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OMT

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

sham comparator: Sham

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.

Interventions

Sham

See description in sham arm.

Osteopathic Manipulation, OMT

See description in OMT arm

Primary outcome measure

  • Latch Score [ Time Frame: Every feeding from birth until first treatment, up to 3 days of life ]
  • Latch Score [ Time Frame: from OMT/Sham until discharge or followup with lactation(4 weeks of life) ]

Central Contacts and Locations

Central contacts

Locations

UnityPoint Methodist Peoria Medical Center

Recruiting

Peoria, Illinois, United States, 61602

Contacts

More Information

Sponsor

Methodist Medical Center of Illinois

Last update posted

May 10, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Medical Center of Illinois on 2019-05-10.