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Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

16. august 2019 opdateret af: De Clifford-Faugère Gwenaelle, St. Justine's Hospital

Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial

Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development. Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited. Thus, we investigated an intervention based on olfactive stimulation with mothers' milk. The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain. Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care. Pain will be measured using a scale of pain adapted for preterm infants. This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

96

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 8 måneder (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria for mothers

  • 18 years or older,
  • speak, understand and write French or English
  • express their milk

Exclusion Criteria for mothers

- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)

Inclusion Criteria for preterm

  • 29 to 36 weeks of gestation
  • APGAR > 6 at 5 minutes
  • less than 21 days

Exclusion Criteria for preterm

  • intubated, under Continuous Positive Airway Pressure or nasal oxygen,
  • surgery in the first day of life
  • congenital disease
  • intraventricular hemorrhage > grade II
  • leukomalacia
  • sedation within 48 hours prior to heel prick
  • pharmacologic treatment for pain within 12 hours prior to heel prick
  • being under phototherapy treatment during the familiarization stage

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Olfactive stimulation intervention with familiarization
Participants will receive the olfactive stimulation intervention with mothers' milk odor during a previous period of nine hours and during heel prick. Sucrose will be also administered during heel prick.
Andet: Olfactive stimulation intervention with familiarization
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick. For the familiarization stage, infants were familiarized with the odor of their mothers' milk for 9 hours before heel prick.
Eksperimentel: Olfactive stimulation intervention
Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick.
Andet: Olfactive stimulation intervention
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
Andet: Standard care
In the control arm, participants will receive the standard care for pain which is sucrose administration.
Andet: Standard care
Preterm infants will receive sucrose during heel prick.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain : Premature Infant Pain Profile-Revised
Tidsramme: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
Scores range from 0 to 21 where a higher score means more pain, a score less than 6 signifies an absence of pain, and a score greater than 12 indicates moderate to severe pain. The PIPP-R contains four parts: gestational age, state of sleep-awake, physiological parameters, and behavioural parameters.
Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recovery
Tidsramme: The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
Maternal acceptability of the olfactive stimulation intervention : questionnaire
Tidsramme: Immediately post-procedure
After the intervention, mothers will be asked to complete a questionnaire focusing on maternal acceptability of the olfactive stimulation intervention with mothers' milk to manage procedural pain (demographic questions and Likert scale).
Immediately post-procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Justine's Hospital

Efterforskere

  • Studieleder: Marilyn Aita, PhD, Université de Montréal

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. september 2019

Primær færdiggørelse (Forventet)

1. december 2020

Studieafslutning (Forventet)

1. december 2020

Datoer for studieregistrering

Først indsendt

12. august 2019

Først indsendt, der opfyldte QC-kriterier

16. august 2019

Først opslået (Faktiske)

20. august 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MP-21-2020-2309

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Olfactive stimulation intervention with familiarization

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