Osteopathic Manipulation in Breastfed Newborns
Osteopathic Manipulation in Breastfed Newborns
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.
This project is an IRB-approved, single-blinded, randomized, controlled, prospective study
 that is currently taking place at two hospitals in Central Illinois. Inclusion criteria
 includes: term infants > 37 weeks gestation in the Level I nursery receiving lactation
 support and identified by lactation as having a newborn component to feeding dysfunction, who
 must be available for at least two inpatient treatment sessions and whose parent has provided
 informed consent.

 All breastfed mother-infant dyads are offered evaluation by a lactation consultant.
 Breastfeeding sessions are routinely scored by either registered nurses or lactation
 consultants using the LATCH tool, with scores entered into a flowsheet on the electronic
 medical record. LATCH is a validated tool designed by Jensen et al to evaluate five
 components of breastfeeding: latch, audible swallowing, type of nipple, comfort of mother,
 and help mother needs holding infant to breast. For the purposes of the study, the nipple
 component will be excluded, so the maximum score will be 8. Eligible infants are enrolled in
 the study by a lactation consultant, who then notifies an on-call physician. The infant's
 mother is provided with a brochure explaining OMT and outlining potential benefits in
 newborns. The on-call physician provides informed consent and performs either the OMT or sham
 protocol. Infants are enrolled Monday through Thursday, and treatments are performed Monday
 through Friday. Enrolled infants are added to a password-protected, numerical list and
 randomized into their group based upon whether they land on an even number (sham) or an odd
 number (OMT). If multiple infants are enrolled at the same time, they are added to the list
 in alphabetical order. Group assignments are blinded to the parents, nursing staff, and
 lactation consultants. A brief note acknowledging that the infant has been enrolled in the
 study is entered into the electronic medical record. The OMT/sham treatments are documented
 on paper; kept in a locked document folder in the residency teaching clinic; and scanned into
 the electronic medical record two weeks after discharge.

 The OMT treatment protocol includes the following four techniques: condylar decompression,
 cervical Still technique, thoracic inlet release and balancing of the hyoid bone. Infants in
 the control arm receive "sham" OMT during which they receive a gentle application of light
 touch but no treatment. A research team physician follows up on the day following enrollment
 to provide a second treatment. After discharge, each enrolled infant's LATCH scores are
 reviewed and documented.

 Based upon results of smaller studies, the investigators hypothesize that infants receiving
 OMT in the treatment arm of the study will have more significant improvement in their LATCH
 score compared to infants in the control arm of the study receiving lactation support alone.
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).