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Probiotics Supplementation in Premature Infants

Primary Purpose

Prematurity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Probiotic supplementation
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring Prematurity, Nutrition, Growth

Eligibility Criteria

1 Day - 8 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Nénatologie, Hôpital Femme Mère Enfant
  • Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
  • Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Maltodextrin

Probiotic B lactis/B longum

Probiotic B longum

Probiotic B lactis

Arm Description

Maltodextrin

Bifidobacterium lactis + Bifidobacterium longum

Bifidobacterium longum

Bifidobacterium lactis

Outcomes

Primary Outcome Measures

Weight (g)

Secondary Outcome Measures

Growth
measured by: weight gain (g/day) height (cm/week) head circumference(cm/week)

Full Information

First Posted
May 10, 2011
Last Updated
August 26, 2011
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01379417
Brief Title
Probiotics Supplementation in Premature Infants
Official Title
Probiotics Supplementation and Nutritional Benefit in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Prematurity, Nutrition, Growth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Arm Title
Probiotic B lactis/B longum
Arm Type
Active Comparator
Arm Description
Bifidobacterium lactis + Bifidobacterium longum
Arm Title
Probiotic B longum
Arm Type
Active Comparator
Arm Description
Bifidobacterium longum
Arm Title
Probiotic B lactis
Arm Type
Active Comparator
Arm Description
Bifidobacterium lactis
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic supplementation
Intervention Description
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Primary Outcome Measure Information:
Title
Weight (g)
Time Frame
From 4 to 6 weeks after inclusion
Secondary Outcome Measure Information:
Title
Growth
Description
measured by: weight gain (g/day) height (cm/week) head circumference(cm/week)
Time Frame
between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
8 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Picaud, Pr
Organizational Affiliation
Hôpital de la Croix-Rousse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Nénatologie, Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69678
Country
France
Facility Name
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26220763
Citation
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.
Results Reference
derived

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Probiotics Supplementation in Premature Infants

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