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

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Other: blood samples, feces samples; Other: blood samples , feces samples

• Registration Number: NCT01177475
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
natural milk	blood samples, feces samples	-
pasteurized milk	blood samples , feces samples	-

Primary Outcome Measures

Name	Time	Method
pasteurized milk	2 years	infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk

Secondary Outcome Measures

Name	Time	Method
natural milk	2 years	infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with natural milk

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France