NCT03945474

Osteopathic Manipulation in Breastfed Newborns

Status unknown NA Last updated 10 May 2019

What this trial tests

NA trial testing Sham in Osteopathic Medicine in 80 participants. Status unknown.

Timeline

10 October 2017

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	Methodist Medical Center of Illinois
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	10 October 2017
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	2 locations across United States

Drugs / interventions tested

• Sham
• Osteopathic Manipulation, OMT

Conditions studied

• Osteopathic Medicine — all drugs for Osteopathic Medicine →
• Breast Feeding — all drugs for Breast Feeding →

Sponsor

Methodist Medical Center of Illinois

Who can join

Adults 20 Hours to 2 Weeks, any sex, with Osteopathic Medicine or Breast Feeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Support for healthy breastfeeding mothers with healthy term babies.
   Gavine A, Shinwell SC, Buchanan P, Farre A, et al · · 2022 · cited 84× · PMID 36282618 · DOI 10.1002/14651858.cd001141.pub6