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OpenTrials
Completed

NCT Number: NCT01177475

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.

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Key information

Age range

1 day–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood samples , feces samples

Other

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

Other

After the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute.

Primary outcomes

  1. pasteurized milk

    Time frame: 2 years

    infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk

Secondary outcomes

  1. natural milk

    Time frame: 2 years

    infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with natural milk

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2010
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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