Neonates AnalgesyNCT02381691
Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
A study testing maternal breast milk odor and no odor in people with Neonates Analgesy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial. Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Neonates Analgesy
- What is being tested?
- maternal breast milk odor and no odor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jan 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 Up to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates fed with their mother breast milk,
- gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days,
- postnatal age ≤ 10 days
- birth weight greater than the 5th percentile according to Olsen curves et al.
- clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease
- the two legal representatives must have signed an informed consent.
Who cannot join
- neonates for whom no video was recorded during the venipuncture
Trial locations and contacts
1 site in 1 country.
About this study
Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.
Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.
- Conditions
- Neonates Analgesy
- Being tested
- maternal breast milk odor, no odor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal breast milk odorOther
no odorOther
| Study group | Role | What they receive |
|---|---|---|
| maternal breast milk odor | Experimental | In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. Receives: Other: maternal breast milk odor |
| no odor | Placebo comparator | In a second control group, venipuncture was performed to the neonate with an odorless diffusor. Receives: Other: no odor |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical score assessment PIPP (Premature Infant Pain Profile)
Measured: 20 minutes
Secondary outcomes (2)
DAN score (Acute Pain of Newborn)
Measured: 20 minutes
salivary cortisol level
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates AnalgesyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Desalbres Urielle, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381691
- Sponsor's protocol ID
- 2012-11
- Other IDs
- RC12_3630, 2012-A00360-43
- Status last verified
- Sep 2015
- First submitted
- 4 Feb 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02381691
- Acronym / sponsor ID
- 2012-11
- Conditions
- Neonates Analgesy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- First posted
- 6 Mar 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.
Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.
Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maternal breast milk odor | Experimental | Other: maternal breast milk odorIn the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. |
| no odor | Placebo comparator | Other: no odorIn a second control group, venipuncture was performed to the neonate with an odorless diffusor. |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- neonates fed with their mother breast milk,
- gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days,
- postnatal age ≤ 10 days
- birth weight greater than the 5th percentile according to Olsen curves et al.
- clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease
Key exclusion criteria (1 listed)
- neonates for whom no video was recorded during the venipuncture
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 |
|---|---|---|
| maternal breast milk odor | Other | maternal breast milk odor |
| no odor | Other | no odor |
Primary outcome
clinical score assessment PIPP (Premature Infant Pain Profile)
Time frame: 20 minutes
2 secondary outcomes
DAN score (Acute Pain of Newborn)
Time frame: 20 minutes
salivary cortisol level
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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.
Desalbres Urielle study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maternal breast milk odor and no odor in people with Neonates Analgesy, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 1 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 1 Oct 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 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?
Results are not available in the source record.
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?
clinical score assessment PIPP (Premature Infant Pain Profile) (time frame: 20 minutes). 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 1 Oct 2015.