Preterm InfantVANILLENCT03626974
The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding
A study testing Venipuncture and Diffuser spreading odor in people with Preterm Infant, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Pain is a frequent occurrence during the early life of premature newborns. Studies on the short term effects of pain, and potential for long-term ones, have shown that pain affects various physiological and behaviorial parameters. Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Venipuncture and Diffuser spreading odor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2019to 7 May 2023
- 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
- Nourished with donated or artificial breast milk
- Term of the certain child
- Child whose post-natal age is less than or equal to 10 days at the time of inclusion
- Eutrophic child
- Child of a non-diabetic mother
- Clinically stable child
Show all 10Show fewer
- Stop Control Positive Airway Pressure (CPAP) nasal for 48 hours.
- No analgesic or sedative drugs since birth
- Child not presenting a gene syndrome, a progressive neurological disease, a malformative pathology, a cleft lip and palate
- Child whose two parents or legal representatives have accepted their child's participation in this study, and have signed informed consent.
Who cannot join
- Hypotrophic child greater than 5th percentile on the curves
- Milk-fed child of a mother born to her own mother
- Child over the age of 10 days
- Child with grade 3-4 intraventricular hemorrhage, periventricular leukomalacia, or ulcerative necrotizing enterocolitis
Trial locations and contacts
1 site in 1 country.
About this study
Pain is a frequent occurrence during the early life of premature newborns. Studies on the short term effects of pain, and potential for long-term ones, have shown that pain affects various physiological and behaviorial parameters. Sucrose during a painful procedure reduce behaviorial and cardiac manifestations in preterm infant, but a recent study casts doubt on its efficacy. Analgesic treatments are available, but a large number of experimental studies in animals ended up with questioning the safety of their use in neonates, particularly in premature ones. Soothing and analgesic methods have been developed such nonnutritive suckling, sucrose, skin to skin contact, and breastfeeding. Therefore, it is important to explore other methods of analgesia. Recently, the role of olfaction as a soothing tool in full term newborns was examined in several studies. The olfactory system is more mature at birth than the others senses. The neonates reacted with significant facial and respiratory changes to low concentration of olfactory stimuli during the various behaviorial states. The analysis of olfacto-facial configurations revealed that behaviorial markers of disgust discriminated between some odors judged as pleasant and unpleasant by adults rather.
Objective The study was designed to assess the analgesic effect of vanilla odor on preterm neonates. The primary outcome was the Premature Infant Pain Profile (PIPP) score. The secondary outcomes were: the French scale Faceless Acute Neonatal pain Scale (FANS), salivary cortisol.
Read more
Study design This is a prospective, randomized, controlled, double-blind and monocentric trial. It is conducted in a level III maternity unit at the North Hospital in Marseille. The infant will feed without their own mother's breast milk, clinically stable, born between 30 and 36 weeks and 6 days gestational age, and of less than 10 days postnatal age. In both groups, the painful stimulus is a venipuncture for blood collection. In the experimental group, called "vanilla odor" group, the venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water. In the control group, the venipuncture will be performed with an odorless diffuser and ingestion of sucrose. Both group have non nutritive sucking. The diffuser will place under a Hood with an air-flow of 7 l/min. It will manually switch on 3 minutes before the venipuncture and switch off 3 minutes later. The type and quantity of vanillin to be used were determined during a pre-testing phase. Assessment Scale shows significant improvement in the neonates, with good interobserver agreement.
Attempt results A current randomized study compare effects of breast milk and vanilla odors, on premature neonate's pain during and after venipuncture. Our previous study has shown that maternal breast milk odor in preterm neonates reduces PIPP scores during a venipuncture and markedly reduces crying after this procedure. Therefore, from a clinical perspective, the odor of mother's own breast milk has an analgesic effect on the premature neonate. Olfactory stimulation using maternal breast milk odor could have other clinical implications in neonatal medicine in addition to pain prevention, as does olfactory stimulation with a pleasant vanilla-based odor. It could be integrated into developmental care of premature neonates.
- Conditions
- Preterm Infant
- Being tested
- Venipuncture, Diffuser spreading odor
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenipunctureBiological
Venipuncture for blood collection
Diffuser spreading odorDevice
Diffuser will place under a Hood with an air-flow
| Study group | Role | What they receive |
|---|---|---|
| Venipuncture with vanilla odor | Experimental | the venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water Receives: Biological: Venipuncture; Device: Diffuser spreading odor |
| Venipuncture without odor | Placebo comparator | the venipuncture will be performed with an odorless diffuser and ingestion of sucrose Receives: Biological: Venipuncture; Device: Diffuser spreading odor |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Premature Infant Pain Profile (PIPP) score.
Expression of behavioral signs after the venipuncture. 7 items including 3 behavioral, 2 physiological and 2 contextual, for a score from 0 to 21 depending on the term of the child. A score of at least 6 indicates a painful condition.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start4 Mar 2019
- Primary completion19 Nov 2019
- Study completion7 May 2023
Why it stopped: investigator is gone
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, ASSISTANCE PUBLIQUE HÔPITAUX MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626974
- Sponsor's protocol ID
- 2017-10
- Other IDs
- 2017-A00496-47
- Acronym
- VANILLE
- Status last verified
- Jun 2023
- First submitted
- 8 Aug 2018
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding
- ClinicalTrials.gov ID
- NCT03626974
- Acronym / sponsor ID
- VANILLE / 2017-10
- Conditions
- Preterm Infant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator is gone
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 7 May 2023 (actual)
- First posted
- 13 Aug 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.
Pain is a frequent occurrence during the early life of premature newborns. Studies on the short term effects of pain, and potential for long-term ones, have shown that pain affects various physiological and behaviorial parameters. Sucrose during a painful procedure reduce behaviorial and cardiac manifestations in preterm infant, but a recent study casts doubt on its efficacy. Analgesic treatments are available, but a large number of experimental studies in animals ended up with questioning the safety of their use in neonates, particularly in premature ones. Soothing and analgesic methods have been developed such nonnutritive suckling, sucrose, skin to skin contact, and breastfeeding. Therefore, it is important to explore other methods of analgesia. Recently, the role of olfaction as a soothing tool in full term newborns was examined in several studies. The olfactory system is more mature at birth than the others senses. The neonates reacted with significant facial and respiratory changes to low concentration of olfactory stimuli during the various behaviorial states. The analysis of olfacto-facial configurations revealed that behaviorial markers of disgust discriminated between some odors judged as pleasant and unpleasant by adults rather.
Objective The study was designed to assess the analgesic effect of vanilla odor on preterm neonates. The primary outcome was the Premature Infant Pain Profile (PIPP) score. The secondary outcomes were: the French scale Faceless Acute Neonatal pain Scale (FANS), salivary cortisol.
Study design This is a prospective, randomized, controlled, double-blind and monocentric trial. It is conducted in a level III maternity unit at the North Hospital in Marseille. The infant will feed without their own mother's breast milk, clinically stable, born between 30 and 36 weeks and 6 days gestational age, and of less than 10 days postnatal age. In both groups, the painful stimulus is a venipuncture for blood collection. In the experimental group, called "vanilla odor" group, the venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water. In the control group, the venipuncture will be performed with an odorless diffuser and ingestion of sucrose. Both group have non nutritive sucking. The diffuser will place under a Hood with an air-flow of 7 l/min. It will manually switch on 3 minutes before the venipuncture and switch off 3 minutes later. The type and quantity of vanillin to be used were determined during a pre-testing phase. Assessment Scale shows significant improvement in the neonates, with good interobserver agreement.
Attempt results A current randomized study compare effects of breast milk and vanilla odors, on premature neonate's pain during and after venipuncture. Our previous study has shown that maternal breast milk odor in preterm neonates reduces PIPP scores during a venipuncture and markedly reduces crying after this procedure. Therefore, from a clinical perspective, the odor of mother's own breast milk has an analgesic effect on the premature neonate. Olfactory stimulation using maternal breast milk odor could have other clinical implications in neonatal medicine in addition to pain prevention, as does olfactory stimulation with a pleasant vanilla-based odor. It could be integrated into developmental care of premature neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venipuncture with vanilla odor | Experimental | Biological: Venipuncture, Device: Diffuser spreading odorthe venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water |
| Venipuncture without odor | Placebo comparator | Biological: Venipuncture, Device: Diffuser spreading odorthe venipuncture will be performed with an odorless diffuser and ingestion of sucrose |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Nourished with donated or artificial breast milk
- Term of the certain child
- Child whose post-natal age is less than or equal to 10 days at the time of inclusion
- Eutrophic child
- Child of a non-diabetic mother
Key exclusion criteria (4 listed)
- Hypotrophic child greater than 5th percentile on the curves
- Milk-fed child of a mother born to her own mother
- Child over the age of 10 days
- Child with grade 3-4 intraventricular hemorrhage, periventricular leukomalacia, or ulcerative necrotizing enterocolitis
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 |
|---|---|---|
| VenipunctureVenipuncture for blood collection | Biological | Venipuncture with vanilla odor, Venipuncture without odor |
| Diffuser spreading odorDiffuser will place under a Hood with an air-flow | Device | Venipuncture with vanilla odor, Venipuncture without odor |
Primary outcome
the Premature Infant Pain Profile (PIPP) score.
Time frame: 36 months
Expression of behavioral signs after the venipuncture. 7 items including 3 behavioral, 2 physiological and 2 contextual, for a score from 0 to 21 depending on the term of the child. A score of at least 6 indicates a painful condition.
Results and safety
The study was stopped early (reason given: investigator is gone). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Olivier ARNAUD, Director study director
ASSISTANCE PUBLIQUE HÔPITAUX MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venipuncture and Diffuser spreading odor in people with Preterm Infant, 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 10 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: stopped early, as of the sponsor's last update on 8 Jun 2023. 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 was stopped early (reason given: investigator is gone). 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?
the Premature Infant Pain Profile (PIPP) score. (time frame: 36 months). 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 8 Jun 2023.