Probiotics Supplementation in Premature Infants

August 26, 2011 updated by: Nestlé

Probiotics Supplementation and Nutritional Benefit in Premature Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69678
        • Service de Nénatologie, Hôpital Femme Mère Enfant
      • Lyon, France, 69317
        • Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
      • Montpellier, France, 34295
        • Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight (g)
Time Frame: From 4 to 6 weeks after inclusion
From 4 to 6 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Jean-Charles Picaud, Pr, Hôpital de la Croix-Rousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04.01.FR.INF
  • 2006-A00062-49 (Other Identifier: DIRECTION GENERALE DE LA SANTE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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