Probiotics Supplementation in Premature Infants

Prematurity Clinical Trial

Official title:

Probiotics Supplementation and Nutritional Benefit in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379417
• Other study ID #: 04.01.FR.INF
• Secondary ID: 2006-A00062-49
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: August 26, 2011
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2011
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : French Health Products Safety Agency (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Dietary Supplement:
• Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion

Locations

Country	Name	City	State
France	Service de Nénatologie, Hôpital Femme Mère Enfant	Bron
France	Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse	Lyon
France	Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (g)		From 4 to 6 weeks after inclusion	Yes
Secondary	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)	Yes