Procedural Pain
Conditions
Keywords
breastmilk, oral sucrose, analgesia, preterm neonates, Neonates
Brief summary
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.
Interventions
OTHERBreastmilk
Breastmilk: 0.2 ml
OTHEROral Sucrose
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
Sponsors
Centre Hospitalier Intercommunal Creteil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 10 Days
Healthy volunteers
No
Inclusion criteria
* preterm neonates born before 27 and 29+6 weeks GA * blood sampling procedure * obtention of parental consent
Exclusion criteria
* congenital malformation * intravenous continuous analgesia * contraindications to feed * high grade intracerebral hemorrhage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose | One time during day 3 or 4 then day 7 to 10 |
Countries
France
Contacts
Primary ContactElodie Zana, MD
Outcome results
None listed