Osteopathic Manipulation in Breastfed Newborns
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|ClinicalTrials.gov Identifier: NCT03945474|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteopathic Medicine Breast Feeding||Other: Sham Other: Osteopathic Manipulation, OMT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients are randomized to either arm, OMT or sham.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||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.|
|Official Title:||Osteopathic Manipulative Treatment(OMT) for the Management of Feeding Dysfunction in Breastfed Newborns|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
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
See description in OMT arm
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.
See description in sham arm.
- Latch Score [ Time Frame: Every feeding from birth until first treatment, up to 3 days of life ]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.
- Latch Score [ Time Frame: from OMT/Sham until discharge or followup with lactation(4 weeks of life) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945474
|Contact: Dominique K Fons, MD||3096725908||Dominique.Fons@unitypoint.org|
|Contact: Kari B Watts, DO||3096725908||Kari.Watts@unitypoint.org|
|United States, Illinois|
|UnityPoint Methodist Peoria Medical Center||Recruiting|
|Peoria, Illinois, United States, 61602|
|Contact: Vaughn Hanna, MD 309-671-8270 firstname.lastname@example.org|
|Contact: Amy Pace 309672672-3118 email@example.com|
|Sub-Investigator: Kari B Watts, DO|
|Sub-Investigator: Holly Vannitamby, DO|
|OSF St. Francis Medical Center||Active, not recruiting|
|Peoria, Illinois, United States, 61637|
|Principal Investigator:||Dominique K Fons, MD||Methodist Medical Center of Illinois|