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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Other: blood samples, feces samples; Other: blood samples , feces samples

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pasteurized milk	infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
natural milk	infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with natural milk	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: CATHERINE GIRE, ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE; Principal Investigator: CATHERINE GIRE, Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimated): August 9, 2010

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: kidney-transplant recipients
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2009-A00666-51; 2009 09 (Other Identifier: AP HM)