The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding
The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding
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.
Inclusion Criteria:

 -  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

 -  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.

 Exclusion Criteria:

 -  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