Clinical trial NCT01177475: Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns
Official title: Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: kidney-transplant recipients
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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 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.

Primary outcomes:
measure: pasteurized milk
timeFrame: 2 years
Secondary outcomes:
measure: natural milk
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE
name: CATHERINE GIRE
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique Hopitaux De Marseille
name: CATHERINE GIRE
role: PRINCIPAL_INVESTIGATOR
References: