PrematurityPhase 4NCT01852500
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
A Phase 4 study of Prematurity, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
Trial summary
Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants. The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order… Read more about this study
- Who is it for?
- Ages 29 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Apr 2011
- Phase
- Phase 4
- 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 29 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preterm infants born at age between 29 and 37 weeks
- sham osteopathic treatment performed < 14 days after birth
- preterm infants born in the same hospital
Who cannot join
- gestational age < 29, > 37 weeks;
- sham osteopathic treatment performed > 14 days after birth;
- newborn transferred to/from other hospital;
- newborn from to HIV seropositive and/or drug addict mother;
- newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.
Trial locations and contacts
1 site in 1 country.
About this study
Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.
The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.
- Conditions
- Prematurity
- Being tested
- Sham Osteopathic Manipulative Treatment, Standard care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Osteopathic Manipulative TreatmentOther
Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.
Standard careOther
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
| Study group | Role | What they receive |
|---|---|---|
| Sham OMT | Experimental | patients under standard medical care plus sham OMT Receives: Other: Sham Osteopathic Manipulative Treatment |
| Control | Other | patients under standard medical care plus only osteopathic evaluation Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of sham OMT in reducing LOS
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (1)
pre-post difference in weight gain
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Cerritelli, DO, MS, Study chair, European Institute for Evidence Based Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852500
- Sponsor's protocol ID
- NEO-Plac 01
- Other IDs
- NEO-Plac 01
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 13 May 2013
- Results posted
- No
Publications
Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.
PubMed 23622070Pizzolorusso 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 21711535
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
- ClinicalTrials.gov ID
- NCT01852500
- Acronym / sponsor ID
- NEO-Plac 01
- Conditions
- Prematurity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 May 2013 (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.
Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.
The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham OMT | Experimental | Other: Sham Osteopathic Manipulative Treatmentpatients under standard medical care plus sham OMT |
| Control | Other | Other: Standard carepatients under standard medical care plus only osteopathic evaluation |
Who may qualify
- Ages
- 29 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm infants born at age between 29 and 37 weeks
- sham osteopathic treatment performed < 14 days after birth
- preterm infants born in the same hospital
Key exclusion criteria (5 listed)
- gestational age < 29, > 37 weeks;
- sham osteopathic treatment performed > 14 days after birth;
- newborn transferred to/from other hospital;
- newborn from to HIV seropositive and/or drug addict mother;
- newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.
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 |
|---|---|---|
| Sham Osteopathic Manipulative TreatmentPatients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit. | Other | Sham OMT |
| Standard carePatients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group. | Other | Control |
Primary outcome
Evaluate the effectiveness of sham OMT in reducing LOS
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
1 secondary outcome
pre-post difference in weight gain
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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 13 May 2013.
- Background: PubMed 23622070Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.
- 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.
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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.
Francesco Cerritelli, DO, MS study chair
European Institute for Evidence Based Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Prematurity, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
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 3 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 13 May 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the effectiveness of sham OMT in reducing LOS (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks). 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 NCT01852500, which also lists 2 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 13 May 2013.