NCT00908401|UnknownPhase 3
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
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BMoS
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
Sponsor study identifier
interventional
42
1 country
1
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 22, 2009
Actual (reported)May 25, 2009
Actual (reported)July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
This group will receive oral sucrose for procedural pain
this group will receive breastmilk as analgesic product to avoid procedural pain
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
Centre Hospitalier Intercommunal de Creteil
Créteil, 94000, France
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.
Elodie Zana, MD
Centre Hospitalier Intercommunal Creteil
First Submitted
May 22, 2009
First Posted
May 25, 2009
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 25, 2009
Record last verified: 2009-05
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