Informations générales (source: ClinicalTrials.gov)

NCT00908401 Statut inconnu
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study (BMoS)
Interventional
  • Douleur liée aux interventions
Phase 3
Centre Hospitalier Intercommunal Creteil (Voir sur ClinicalTrials)
avril 2009
juillet 2009
29 juin 2024
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHI DE CRETEIL En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- preterm neonates born before 27 and 29+6 weeks GA

- blood sampling procedure

- obtention of parental consent


- congenital malformation

- intravenous continuous analgesia

- contraindications to feed

- high grade intracerebral hemorrhage