Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteopathic Manipulation in Breastfed Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945474
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
University of Illinois College of Medicine at Peoria
OSF St. Francis Medical Center
Information provided by (Responsible Party):
Methodist Medical Center of Illinois

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.


Condition or disease Intervention/treatment Phase
Osteopathic Medicine Breast Feeding Other: Sham Other: Osteopathic Manipulation, OMT Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: OMT
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.
Other: Sham
See description in sham arm.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Dominique K Fons, MD 3096725908 Dominique.Fons@unitypoint.org
Contact: Kari B Watts, DO 3096725908 Kari.Watts@unitypoint.org

Locations
Layout table for location information
United States, Illinois
UnityPoint Methodist Peoria Medical Center Recruiting
Peoria, Illinois, United States, 61602
Contact: Vaughn Hanna, MD    309-671-8270    vaughn.hanna@unitypoint.org   
Contact: Amy Pace    309672672-3118    amy.pace@unitypoint.org   
Sub-Investigator: Kari B Watts, DO         
Sub-Investigator: Holly Vannitamby, DO         
OSF St. Francis Medical Center Active, not recruiting
Peoria, Illinois, United States, 61637
Sponsors and Collaborators
Methodist Medical Center of Illinois
University of Illinois College of Medicine at Peoria
OSF St. Francis Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Dominique K Fons, MD Methodist Medical Center of Illinois
  Study Documents (Full-Text)

Documents provided by Methodist Medical Center of Illinois:
Informed Consent Form  [PDF] April 12, 2019
Study Protocol  [PDF] April 12, 2019

Publications:

Layout table for additonal information
Responsible Party: Methodist Medical Center of Illinois
ClinicalTrials.gov Identifier: NCT03945474    
Other Study ID Numbers: 986099
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No