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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01379417 |
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Date of registration:
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10/05/2011 |
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Primary sponsor: |
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Public title:
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Probiotics Supplementation in Premature Infants
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Scientific title:
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Probiotics Supplementation and Nutritional Benefit in Premature Infants |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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199 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01379417 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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France
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Contacts
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Name:
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Jean-Charles Picaud, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital de la Croix Rousse |
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Key inclusion & exclusion criteria
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Inclusion criteria
- Gestational age between 26 weeks and 31 weeks
- 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
Non inclusion criteria
- 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
- Enteral/Oral feeding termination during more than 72 hours due to severe digestive
disorders (> or equal to 2a on Bell stage )
- Serious digestive surgery
Age minimum:
N/A
Age maximum:
8 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prematurity
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Intervention(s)
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Dietary Supplement: Probiotic supplementation
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Primary Outcome(s)
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Weight (g)
[Time Frame: From 4 to 6 weeks after inclusion]
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Secondary Outcome(s)
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Growth
[Time Frame: between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)]
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Secondary ID(s)
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04.01.FR.INF
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2006-A00062-49
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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