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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sucrose | Active Comparator | This group will receive oral sucrose for procedural pain |
|
| breastmilk | Experimental | this group will receive breastmilk as analgesic product to avoid procedural pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastmilk | Other | Breastmilk: 0.2 ml |
| |
| Oral Sucrose |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elodie Zana, MD | Contact | +33 1 45 17 54 39 | Elodie.Zana@chicreteil.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elodie Zana, MD | Centre Hospitalier Intercommunal Creteil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal de Creteil | Recruiting | Créteil | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15188969 | Background | 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. | |
| 12511452 | Background | 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. |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Other |
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier |
|
| 9295899 | Background | 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. |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000073893 |
| Sugars |