Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03626974
Other study ID # 2017-10
Secondary ID 2017-A00496-47
Status Terminated
Phase N/A
First received
Last updated
Start date March 4, 2019
Est. completion date May 7, 2023

Study information

Verified date June 2023
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date May 7, 2023
Est. primary completion date November 19, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 10 Days
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Venipuncture
Venipuncture for blood collection
Device:
Diffuser spreading odor
Diffuser will place under a Hood with an air-flow

Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 36 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04062513 - Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response N/A
Completed NCT03412578 - Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants N/A
Completed NCT03166722 - Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition N/A
Enrolling by invitation NCT03212547 - The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal. N/A
Completed NCT03931902 - The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates N/A
Completed NCT03302000 - Visual Stimulation of Preterm Infants N/A
Completed NCT03731546 - Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency N/A
Completed NCT03104946 - To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants N/A
Completed NCT03704012 - Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Active, not recruiting NCT03232931 - Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants N/A
Completed NCT03242057 - Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA N/A
Completed NCT04089540 - New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates N/A
Not yet recruiting NCT02528851 - Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants N/A
Completed NCT01959737 - Delivery Room Skin-to-skin Study N/A
Completed NCT03700463 - Executive Functions and Preterm Children in 3 to 4 Year Old
Completed NCT02811432 - Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa N/A
Completed NCT03728764 - Growth and Safety of a Two-stage Feeding System in Preterm Infants N/A
Completed NCT04382976 - The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
Completed NCT03748914 - C-UCM and Cerebral Oxygenation and Perfusion N/A