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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177475
• Other study ID #: 2009-A00666-51
• Secondary ID: 2009 09
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: September 29, 2015
• Start date: February 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pasteurized milk	infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk	2 years	No
Secondary	natural milk	infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with natural milk	2 years	No