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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01177475
First received: March 18, 2010
Last updated: August 6, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Premature Birth
 Other: blood samples , feces samples
Other: blood samples, feces samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • pasteurized milk [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk


Secondary Outcome Measures:
  • natural milk [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with natural milk


Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: natural milk Other: blood samples, feces samples
After the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute.
Experimental: pasteurized milk Other: blood samples , feces samples
After the 32nd week until the 36th week or the end of hospitalization,infants received mother's native milk or substitute.

Detailed Description:

One hundred infants born between 28 and 30 weeks of gestational age will be enrolled in our clinical trial in two neonatal units of Marseille; they will receive small enteral feeding protocol with natural or pasteurized milk (according to the Neonatology Department). Infants monitoring will be conducted from birth until 32 weeks of gestational age through extra-uterine growth, dietary type evolution and determination of gut maturation markers levels in blood (Triglycerides and Cholesterol, PUFA, GLP-2, I and L-FABP, Gastrin, Citrullin) and faeces (Calprotectine). We will also look for new biological markers of intestinal growth, via metabolomic approach. Consumption of bioactives molecules (PUFA, sphingomyelin, sCD14, insulin, leptin, lactoferrin, sphingomyelinase acid and BSSL activity) will be quantified in milk 24h-representative samples received by each newborn. The benefits on digestive tract physiology evolution due to the molecules consumption will be observed from the 32nd week until the 36th week or the end of hospitalization.

  Eligibility

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177475

Contacts
Contact: CATHERINE GIRE catherine.gire@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France
Contact: CATHERINE GIRE            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: CATHERINE GIRE ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE
Principal Investigator: CATHERINE GIRE Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01177475     History of Changes
Other Study ID Numbers: 2009-A00666-51, 2009 09
Study First Received: March 18, 2010
Last Updated: August 6, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
kidney-transplant recipients

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013