Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns

NCT01177475 | Completed

• 2 other identifiers: 2009-A00666-512009 09
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial.

Conditions

Premature Birth

Keywords

kidney-transplant recipients

Outcome Measures

Primary Outcomes (1)

• pasteurized milk

  infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk

  2 years

Secondary Outcomes (1)

• natural milk

  2 years

Study Arms (2)

natural milk

ACTIVE COMPARATOR

pasteurized milk

EXPERIMENTAL

Other: blood samples , feces samples

Interventions

blood samples, feces samples OTHER

After the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute.

Eligibility Criteria

• Age: 1 Day - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children whose term is understood(included) between 28 (27SA+6j past(over)) and 30 LIMITED COMPANIES (30 SA+6j).
• Children fed by digestive stimulation.
• Children in 1st day of food(supply)
• Term of certain child.
• Children not presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
• Children among whom both holders of the parental authority are of more than 18 years old and are not major protected by the law or deprived of freedom.
• Children among whom the relatives(parents) or the legal representatives accepted the participation of their child in this study, and having signed a lit(enlightened) consent.

You may not qualify if:

• Children been born \> 30 LIMITED COMPANIES and \< 28 limited companies.
• Children presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
• Children among whom the relatives(parents) or the legal representatives refused that their child participates in the study.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

Related Publications (1)

• Garcia C, Duan RD, Brevaut-Malaty V, Gire C, Millet V, Simeoni U, Bernard M, Armand M. Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand). 2013 Dec 30;59(1):108-31.

  PMID: 25326648 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• CATHERINE GIRE

  ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE

  PRINCIPAL INVESTIGATOR

• CATHERINE GIRE

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: August 9, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 7, 2026

Record last verified: 2015-09

Locations

FR (1)