Newborn ComplicationNCT03751787
Cranial Osteopathy in Functional Disorders of the Newborn
A study testing cranial osteopathy and comfort massage in people with Newborn Complication, run by University Hospital, Lille at 1 site in France.
Trial summary
To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities Read more about this study
- Who is it for?
- Ages 1 minute to 29 days
- Conditions the study is for
- Newborn Complication
- What is being tested?
- cranial osteopathy and comfort massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Oct 2016
- 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 1 minute to 29 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns:
- forward
- born vaginally or cesarean section
- with or without general anesthesia
- with or without epidural or spinal anesthesia
- with or without instrumental extraction
- presenting at least 1 of the 4 criteria detailed above, numbered at 3 or 4 or two criteria at 2
Who cannot join
- Newborns presenting:
- a score of Amiel <7, signing a strong suspicion of non-integrity of brain functions (see table) and therefore leaving the framework of functional pathology
- symptomatic maternal-fetal infection
- true obstetric trauma: brachial plexus paralysis, fracture
- or of a mother who has taken during pregnancy drugs or toxic drugs that affect the behavior of the newborn. (benzodiazepines, subutex, methadone, cocaine, heroin or cannabis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn
To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities
- Conditions
- Newborn Complication
- Being tested
- cranial osteopathy, comfort massage
- Keywords
- osteopathy, cranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranial osteopathyOther
two sessions at three weeks intervals
comfort massageOther
manipulation, comfort massage, standardized and not affecting the skull
| Study group | Role | What they receive |
|---|---|---|
| cranial osteopathy | Experimental | The group will receive treatment with osteopathic cranial osteopathy Receives: Other: cranial osteopathy |
| comfort massage | Placebo comparator | The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy. Receives: Other: comfort massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hyper irritability
Reduction of hyper irritability will be done by evaluation from a clinical score,signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2:
- Excessive and difficult to calm, insufficient sleep
- postural asymmetry
- difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling
- Excessive regurgitation
Measured: at 28 days of life.
Secondary outcomes (1)
Reduction of hyper irritability
Reduction of hyper irritability will be done by evaluation from a clinical score, signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2:
- Excessive and difficult to calm, insufficient sleep
- postural asymmetry
- difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling
- Excessive regurgitation
Measured: before any treatment, at 3 days after deliverance and at 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startSep 2009
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Boez, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751787
- Sponsor's protocol ID
- 2008_43
- Other IDs
- 2009-A00037-50
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn
- ClinicalTrials.gov ID
- NCT03751787
- Acronym / sponsor ID
- 2008_43
- Conditions
- Newborn Complication
- Keywords
- osteopathy, cranial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Nov 2018 (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.
To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cranial osteopathy | Experimental | Other: cranial osteopathyThe group will receive treatment with osteopathic cranial osteopathy |
| comfort massage | Placebo comparator | Other: comfort massageThe group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy. |
Who may qualify
- Ages
- 1 minute to 29 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Newborns:
Key exclusion criteria (5 listed)
- Newborns presenting:
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 |
|---|---|---|
| cranial osteopathytwo sessions at three weeks intervals | Other | cranial osteopathy |
| comfort massagemanipulation, comfort massage, standardized and not affecting the skull | Other | comfort massage |
Primary outcome
Reduction of hyper irritability
Time frame: at 28 days of life.
Reduction of hyper irritability will be done by evaluation from a clinical score,signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2: * Excessive and difficult to calm, insufficient sleep * postural asymmetry * difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling * Excessive regurgitation
1 secondary outcome
Reduction of hyper irritability
Time frame: before any treatment, at 3 days after deliverance and at 28 days of life
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 23 Nov 2018.
- 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.
Eric Boez, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cranial osteopathy and comfort massage in people with Newborn Complication, run by University Hospital, Lille at 1 site in France.
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 7 inclusion and 5 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 23 Nov 2018. 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 France. 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?
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?
Reduction of hyper irritability (time frame: at 28 days of life.). 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 23 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.