Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature

• Conditions: Premature Birth

• Registration Number: NCT03662503
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child's health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.

The optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.

The optimization of nutrition in premature children is therefore a topical issue in neonatology.

Our project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA (week of amenorrhea) to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.

Nutritional intake during the first week of life will be analyzed in tertile. Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group).

The primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition".

The benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.

Detailed Description

The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child's health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.

The optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.

The optimization of nutrition in premature children is therefore a topical issue in neonatology.

Our project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.

Nutritional intake (calorie intake and total protein intake) during the first week of life will be analyzed in tertile.

Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group).

The primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition".

The benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Study First Posted: 2018-09-07
• Last Update Posted: 2018-09-07
• Study Start: 2018-12
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Children born prematurely between 30 WA (week of amenorrhea) and 32 WA + 6 days
• Included in the cohort EPIPAGE 2 with more than 4500 inclusions. The data Perinatal, neonatal and neuro-cognitive outcome at 2 years are available.
• This will include 2,000 children meeting these criteria.

Exclusion Criteria

• Children with chromosomal abnormalities or malformations congenital
• Children who died during the neonatal period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
height	36 weeks	height in centimeters will be evaluate between birth and age (36 adjusted age SA)
head circumference	36 weeks	head circumference in centimeters will be evaluate between birth and age (36 adjusted age SA)
weight	36 weeks	weight in kilograms will be evaluate between birth and age (36 adjusted age SA)

Trial Locations

Locations (1)

Assistance Publique Des Hopitaux de Marseille; 🇫🇷 Marseille, Paca, France