Probiotics Supplementation in Premature Infants

Nestlé

Status: Completed

Conditions: Prematurity

Treatments: Dietary Supplement: Probiotic supplementation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01379417

04.01.FR.INF

2006-A00062-49 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 1 to 8 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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199 participants in 4 patient groups, including a placebo group

Maltodextrin

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Probiotic supplementation

Probiotic B lactis/B longum

Active Comparator group

Description:

Bifidobacterium lactis + Bifidobacterium longum

Treatment:

Dietary Supplement: Probiotic supplementation

Probiotic B longum

Active Comparator group

Description:

Bifidobacterium longum

Treatment:

Dietary Supplement: Probiotic supplementation

Probiotic B lactis

Active Comparator group

Description:

Bifidobacterium lactis

Treatment:

Dietary Supplement: Probiotic supplementation