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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants

NCT00711633

Preterms With Gestational Age Ranging From 30 to 35 Weeks

COMPLETED NA

The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies

NCT06072976

Gastrointestinal Complication Intestinal Obstruction Gastroschisis +3 more

UNKNOWN NA

Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum

NCT05481866

Gut Microbiota Metabolites

UNKNOWN NA

Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns

NCT02112331

Premature Birth

COMPLETED NA

Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil

NCT01177605

Gastrointestinal Problems

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

natural milk

Group Type ACTIVE_COMPARATOR

blood samples, feces samples

Intervention Type OTHER

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

pasteurized milk

Group Type EXPERIMENTAL

blood samples , feces samples

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No