Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
NCT ID: NCT00908401
Last Updated: 2009-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
42 participants
INTERVENTIONAL
2009-04-30
2009-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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sucrose
This group will receive oral sucrose for procedural pain
Oral Sucrose
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
breastmilk
this group will receive breastmilk as analgesic product to avoid procedural pain
Breastmilk
Breastmilk: 0.2 ml
Interventions
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Breastmilk
Breastmilk: 0.2 ml
Oral Sucrose
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
Eligibility Criteria
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Inclusion Criteria
* blood sampling procedure
* obtention of parental consent
Exclusion Criteria
* intravenous continuous analgesia
* contraindications to feed
* high grade intracerebral hemorrhage
3 Days
10 Days
ALL
No
Sponsors
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Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Centre Hospitalier Intercommunal de Creteil
Principal Investigators
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Elodie Zana, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Intercommunal Creteil
Locations
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Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Countries
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Central Contacts
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References
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Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. doi: 10.1080/08035250410027959.
Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. doi: 10.1016/s0929-693x(97)83360-x. French.
Other Identifiers
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CHICreteil
Identifier Type: -
Identifier Source: org_study_id
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