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The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding (VANILLE)

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ClinicalTrials.gov Identifier: NCT03626974
Recruitment Status : Unknown
Verified August 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Preterm Infant Biological: Venipuncture Device: Diffuser spreading odor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : November 28, 2020
Estimated Study Completion Date : November 28, 2020

Arm Intervention/treatment
Experimental: Venipuncture with vanilla odor
the venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water
Biological: Venipuncture
Venipuncture for blood collection

Device: Diffuser spreading odor
Diffuser will place under a Hood with an air-flow

Placebo Comparator: Venipuncture without odor
the venipuncture will be performed with an odorless diffuser and ingestion of sucrose
Biological: Venipuncture
Venipuncture for blood collection

Device: Diffuser spreading odor
Diffuser will place under a Hood with an air-flow




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626974


Contacts
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Contact: Muriel BUSUTTIL, PH 491968750 ext +33 muriel.BUSUTTIL@ap-hm.fr
Contact: Catherine GIRE, PH 491968750 ext +33 catherien.gire@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Muriel BUSUTTIL, PH    491968750 ext +33    muriel.busuttil@ap-hm.fr   
Principal Investigator: Catherine GIRE, PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director ASSISTANCE PUBLIQUE HÔPITAUX MARSEILLE
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03626974    
Other Study ID Numbers: 2017-10
2017-A00496-47 ( Registry Identifier: ID RCB )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications