Osteopathic MedicineNCT03945474
Osteopathic Manipulation in Breastfed Newborns
A study testing Osteopathic Manipulation, OMT in people with Osteopathic Medicine and Breast Feeding, run by Methodist Medical Center of Illinois at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 hours to 2 weeks
- Conditions the study is for
- Osteopathic Medicine, Breast Feeding
- What is being tested?
- Osteopathic Manipulation, OMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 hours to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
UnityPoint Methodist Peoria Medical Center
Peoria, Illinois, 61602
Vaughn Hanna, MD, 309-671-8270, vaughn.hanna@unitypoint.org
Amy Pace, 309672672-3118, amy.pace@unitypoint.org
- Active, not recruiting
OSF St. Francis Medical Center
Peoria, Illinois, 61637
About this study
Official title: Osteopathic Manipulative Treatment(OMT) for the Management of Feeding Dysfunction 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.
Read the 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.
- Conditions
- Osteopathic Medicine, Breast Feeding
- Being tested
- Sham, Osteopathic Manipulation, OMT
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShamOther
See description in sham arm.
Osteopathic Manipulation, OMTOther
See description in OMT arm
| Study group | Role | What they receive |
|---|---|---|
| OMT | Experimental | Patients will receive a standardized protocol of: condylar decompression, Still's technique for the sternocleidomastoid, hyoid rebalancing and thoracic inlet myofascial release. Receives: Other: Osteopathic Manipulation, OMT |
| Sham | Sham comparator | 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latch Score
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.
Measured: Every feeding from birth until first treatment, up to 3 days of life
Latch Score
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.
Measured: from OMT/Sham until discharge or followup with lactation(4 weeks of life)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start10 Oct 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteopathic MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized to either arm, OMT or sham.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Medical Center of Illinois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria, OSF Healthcare System
- Responsible party
- Sponsor
- Investigators
- Dominique K Fons, MD, Principal investigator, Methodist Medical Center of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945474
- Sponsor's protocol ID
- 986099
- Status last verified
- May 2019
- First submitted
- 23 Apr 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pizzolorusso G, Cerritelli F, D'Orazio M, Cozzolino V, Turi P, Renzetti C, Barlafante G, D'Incecco C. Osteopathic evaluation of somatic dysfunction and craniosacral strain pattern among preterm and term newborns. J Am Osteopath Assoc. 2013 Jun;113(6):462-7.
PubMed 23739757Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
PubMed 21711535Riordan J, Bibb D, Miller M, Rawlins T. Predicting breastfeeding duration using the LATCH breastfeeding assessment tool. J Hum Lact. 2001 Feb;17(1):20-3. doi: 10.1177/089033440101700105.
PubMed 11847847Herzhaft-Le Roy J, Xhignesse M, Gaboury I. Efficacy of an Osteopathic Treatment Coupled With Lactation Consultations for Infants' Biomechanical Sucking Difficulties. J Hum Lact. 2017 Feb;33(1):165-172. doi: 10.1177/0890334416679620. Epub 2016 Dec 27.
PubMed 28027445Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.
PubMed 17062784Lund GC, Edwards G, Medlin B, Keller D, Beck B, Carreiro JE. Osteopathic manipulative treatment for the treatment of hospitalized premature infants with nipple feeding dysfunction. J Am Osteopath Assoc. 2011 Jan;111(1):44-8. doi: 10.7556/jaoa.2011.111.1.44.
PubMed 21258016Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
PubMed 8176525
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment(OMT) for the Management of Feeding Dysfunction in Breastfed Newborns
- ClinicalTrials.gov ID
- NCT03945474
- Acronym / sponsor ID
- 986099
- Conditions
- Osteopathic Medicine, Breast Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Methodist Medical Center of IllinoisUniversity, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria, OSF Healthcare System
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients are randomized to either arm, OMT or sham.
| Arm | Type | Receives |
|---|---|---|
| OMT | Experimental | Other: Osteopathic Manipulation, OMTPatients will receive a standardized protocol of: condylar decompression, Still's technique for the sternocleidomastoid, hyoid rebalancing and thoracic inlet myofascial release. |
| Sham | Sham comparator | Other: ShamPatient 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. |
Who may qualify
- Ages
- 20 hours to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- infants <37 weeks gestation
- Level II or III nursery status
- wards of the state
- receiving speech or physical therapy
- currently receiving OMT, bottlefed infants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShamSee description in sham arm. | Other | Sham |
| Osteopathic Manipulation, OMTSee description in OMT arm | Other | OMT |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 23739757Pizzolorusso G, Cerritelli F, D'Orazio M, Cozzolino V, Turi P, Renzetti C, Barlafante G, D'Incecco C. Osteopathic evaluation of somatic dysfunction and craniosacral strain pattern among preterm and term newborns. J Am Osteopath Assoc. 2013 Jun;113(6):462-7.
- Background: PubMed 21711535Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
- Background: PubMed 11847847Riordan J, Bibb D, Miller M, Rawlins T. Predicting breastfeeding duration using the LATCH breastfeeding assessment tool. J Hum Lact. 2001 Feb;17(1):20-3. doi: 10.1177/089033440101700105.
- Background: PubMed 28027445Herzhaft-Le Roy J, Xhignesse M, Gaboury I. Efficacy of an Osteopathic Treatment Coupled With Lactation Consultations for Infants' Biomechanical Sucking Difficulties. J Hum Lact. 2017 Feb;33(1):165-172. doi: 10.1177/0890334416679620. Epub 2016 Dec 27.
- Background: PubMed 17062784Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.
- Background: PubMed 21258016Lund GC, Edwards G, Medlin B, Keller D, Beck B, Carreiro JE. Osteopathic manipulative treatment for the treatment of hospitalized premature infants with nipple feeding dysfunction. J Am Osteopath Assoc. 2011 Jan;111(1):44-8. doi: 10.7556/jaoa.2011.111.1.44.
- Background: PubMed 8176525Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique K Fons, MD principal investigator
Methodist Medical Center of Illinois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulation, OMT in people with Osteopathic Medicine and Breast Feeding, run by Methodist Medical Center of Illinois at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique K Fons, MD (3096725908, Dominique.Fons@unitypoint.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latch Score (time frame: Every feeding from birth until first treatment, up to 3 days of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945474, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.