Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
BMoS
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMay 25, 2009
May 1, 2009
3 months
May 22, 2009
May 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
sucrose
ACTIVE COMPARATORThis group will receive oral sucrose for procedural pain
breastmilk
EXPERIMENTALthis group will receive breastmilk as analgesic product to avoid procedural pain
Interventions
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
Eligibility Criteria
You may qualify if:
- preterm neonates born before 27 and 29+6 weeks GA
- blood sampling procedure
- obtention of parental consent
You may not qualify if:
- congenital malformation
- intravenous continuous analgesia
- contraindications to feed
- high grade intracerebral hemorrhage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Intercommunal de Creteil
Créteil, 94000, France
Related Publications (3)
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.
PMID: 15188969BACKGROUNDCarbajal 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.
PMID: 12511452BACKGROUNDCarbajal 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.
PMID: 9295899BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elodie Zana, MD
Centre Hospitalier Intercommunal Creteil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 22, 2009
First Posted
May 25, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 25, 2009
Record last verified: 2009-05