Probiotics Supplementation in Premature Infants

Study Overview
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Brief Summary
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The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.

Official Title
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Probiotics Supplementation and Nutritional Benefit in Premature Infants

Conditions
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Prematurity

Intervention / Treatment
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* Dietary Supplement: Probiotic supplementation


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 8 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br>Maltodextrin | Dietary Supplement: Probiotic supplementation<br>* 1 capsule per day, from inclusion to 4 or 6 weeks after inclusion<br>|
| Active Comparator: Probiotic B lactis/B longum<br>Bifidobacterium lactis + Bifidobacterium longum | Dietary Supplement: Probiotic supplementation<br>* 1 capsule per day, from inclusion to 4 or 6 weeks after inclusion<br>|
| Active Comparator: Probiotic B longum<br>Bifidobacterium longum | Dietary Supplement: Probiotic supplementation<br>* 1 capsule per day, from inclusion to 4 or 6 weeks after inclusion<br>|
| Active Comparator: Probiotic B lactis<br>Bifidobacterium lactis | Dietary Supplement: Probiotic supplementation<br>* 1 capsule per day, from inclusion to 4 or 6 weeks after inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (g) |  | From 4 to 6 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | measured by: weight gain (g/day) height (cm/week) head circumference(cm/week) | between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth, Prematurity, Nutrition