BreastfeedingNCT02407860
Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn
A study testing osteopathic treatment and usual breastfeeding counselling in people with Breastfeeding, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Breastfeeding is the physiological and recommended way of feeding newborns as indicated by the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in Quebec. Despite these, mothers who exclusively breastfed their babies are rare. Read more about this study
- Who is it for?
- Ages 48 hours to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- osteopathic treatment and usual breastfeeding counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Dec 2015
- 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 48 hours to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term newborn,
- mechanical suckling dysfunction, assessed by lactation consultant or midwives or healthcare professionals with breastfeeding experience.
Who cannot join
- breastfeeding difficulties from mother (hypogalactia, breast hypoplasia, medication),
- twins or more,
- tongue-tie or lip tie pending for surgical treatment,
- previous or current bodywork (chiropractic, osteopathy, physiotherapy, ergotherapy, craniosacral therapy).
Trial locations and contacts
1 site in 1 country.
About this study
Breastfeeding is the physiological and recommended way of feeding newborns as indicated by the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to Statistics Canada, the first month of life is the most at risk time to wean because of technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite a supportive network of health care professionals including lactation consultant, many babies are weaned. Lactation consultant are often feeling helpless when facing these mechanical difficulties.
The purpose of this study is to determine the efficiency of an osteopathic treatment for newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is that an osteopathic treatment integrating in the usual care is more efficient than usual car alone to help healing mechanical breastfeeding issues.
Read more
The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The control group will receive usual care with a lactation consultant and the intervention group will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial: the osteopath finds out, prior to evaluating the patient, what intervention should be delivered to the baby (assessment alone or standardized osteopathic treatment for infant).
The results will ultimately lead to improvements in the existing knowledge on the fields of osteopathy and lactation support, allowing implementation of osteopathic care in the perinatal network.
- Conditions
- Breastfeeding
- Being tested
- osteopathic treatment, usual breastfeeding counselling
- Keywords
- breast feeding, sucking, dysfunction, Latch assessment tool, visual analogic scale, infant physiology
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic treatmentOther
Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.
usual breastfeeding counsellingOther
breastfeeding counselling and support by lactation consultant
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | one single osteopathic treatment in addition to usual breastfeeding counselling Receives: Other: osteopathic treatment |
| control | Active comparator | usual breastfeeding counselling. Osteopathic evaluation of entire body Receives: Other: usual breastfeeding counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in baby's latch at the breast
Latch assessment tool (Jensen, Wallace \& Kelsay; 1994)
Measured: Immediately after the intervention and 2 days post-intervention
Secondary outcomes (5)
Change from baseline in numbers of feeds per day
Home made questionnaire with close-ended questions
Measured: Immediately after the intervention and 2, and 10 days post-intervention
Change from baseline in devices used to feed the baby
Home made questionnaire with open-ended and close-ended questions, including the number of bottles the day before.
Measured: 2 and 10 days post-intervention
Change from baseline in mother's nipple pain
Visual analog scale from 0 (no pain) to 10 (extreme pain)
Measured: Immediately after the intervention and 2, and 10 days post-intervention
Change from baseline in baby's head rotation
Assessment of baby's ability to rotate his/her head on left and right compared to a baseline evaluation prior to the intervention, using a goniometer
Measured: Immediately after the intervention
Mother's satisfaction with an osteopathic approach
Likert scale to assess the mother's perception of an osteopathic approach with four items: not at all satisfied, somewhat satisfied, satisfied and very satisfied
Measured: 10 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Gaboury, Université de Sherbrooke
- Investigators
- Isabelle Gaboury, PhD, Study director, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407860
- Sponsor's protocol ID
- 14-116
- Status last verified
- Dec 2015
- First submitted
- 10 Mar 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn
- ClinicalTrials.gov ID
- NCT02407860
- Acronym / sponsor ID
- 14-116
- Conditions
- Breastfeeding
- Keywords
- breast feeding, sucking, dysfunction, Latch assessment tool, visual analogic scale, infant physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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.
Breastfeeding is the physiological and recommended way of feeding newborns as indicated by the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to Statistics Canada, the first month of life is the most at risk time to wean because of technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite a supportive network of health care professionals including lactation consultant, many babies are weaned. Lactation consultant are often feeling helpless when facing these mechanical difficulties.
The purpose of this study is to determine the efficiency of an osteopathic treatment for newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is that an osteopathic treatment integrating in the usual care is more efficient than usual car alone to help healing mechanical breastfeeding issues.
The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The control group will receive usual care with a lactation consultant and the intervention group will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial: the osteopath finds out, prior to evaluating the patient, what intervention should be delivered to the baby (assessment alone or standardized osteopathic treatment for infant).
The results will ultimately lead to improvements in the existing knowledge on the fields of osteopathy and lactation support, allowing implementation of osteopathic care in the perinatal network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Other: osteopathic treatmentone single osteopathic treatment in addition to usual breastfeeding counselling |
| control | Active comparator | Other: usual breastfeeding counsellingusual breastfeeding counselling. Osteopathic evaluation of entire body |
Who may qualify
- Ages
- 48 hours to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy term newborn,
- mechanical suckling dysfunction, assessed by lactation consultant or midwives or healthcare professionals with breastfeeding experience.
Key exclusion criteria (4 listed)
- breastfeeding difficulties from mother (hypogalactia, breast hypoplasia, medication),
- twins or more,
- tongue-tie or lip tie pending for surgical treatment,
- previous or current bodywork (chiropractic, osteopathy, physiotherapy, ergotherapy, craniosacral therapy).
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 |
|---|---|---|
| osteopathic treatmentTreatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results. | Other | treatment |
| usual breastfeeding counsellingbreastfeeding counselling and support by lactation consultant | Other | control |
Primary outcome
Change from baseline in baby's latch at the breast
Time frame: Immediately after the intervention and 2 days post-intervention
Latch assessment tool (Jensen, Wallace \& Kelsay; 1994)
5 secondary outcomes
Change from baseline in numbers of feeds per day
Time frame: Immediately after the intervention and 2, and 10 days post-intervention
Change from baseline in devices used to feed the baby
Time frame: 2 and 10 days post-intervention
Change from baseline in mother's nipple pain
Time frame: Immediately after the intervention and 2, and 10 days post-intervention
Change from baseline in baby's head rotation
Time frame: Immediately after the intervention
Mother's satisfaction with an osteopathic approach
Time frame: 10 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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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.
Isabelle Gaboury, PhD study director
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic treatment and usual breastfeeding counselling in people with Breastfeeding, run by Université de Sherbrooke at 1 site in Canada.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in baby's latch at the breast (time frame: Immediately after the intervention and 2 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2015.