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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COMPLETED
NA
199 participants
INTERVENTIONAL
2007-11-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Maltodextrin
Maltodextrin
Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Probiotic B lactis/B longum
Bifidobacterium lactis + Bifidobacterium longum
Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Probiotic B longum
Bifidobacterium longum
Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Probiotic B lactis
Bifidobacterium lactis
Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Interventions
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Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Eligibility Criteria
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Inclusion Criteria
* Birth weight between 700 to 1600 g
* Eutrophic infants (weight between -2 to 2 DS, Usher curves)
* Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
* Still on parenteral feeding or infusion on the 5th day of birth
* Digestive disorders \> or equal to 1b on Bell stage
* Severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life.
* Severe malformations or digestive malformations
* No antenatal corticosteroid therapy
* Severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (Hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis).
* Parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age)
Exclusion Criteria
* Serious digestive surgery
1 Day
8 Days
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Charles Picaud, Pr
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Croix-Rousse
Locations
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Service de Nénatologie, Hôpital Femme Mère Enfant
Bron, , France
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, , France
Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve
Montpellier, , France
Countries
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References
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Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.
Other Identifiers
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2006-A00062-49
Identifier Type: OTHER
Identifier Source: secondary_id
04.01.FR.INF
Identifier Type: -
Identifier Source: org_study_id
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