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Completed

NCT Number: NCT01379417

Probiotics Supplementation 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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Nénatologie, Hôpital Femme Mère Enfant, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic supplementation

Dietary Supplement

1 capsule per day, from inclusion to 4 or 6 weeks after inclusion

Primary outcomes

  1. Weight (g)

    Time frame: From 4 to 6 weeks after inclusion

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Probiotics Supplementation and Nutritional Benefit in Premature Infants

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2011
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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