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

NCT03662503 | Unknown

• 1 other identifier: 2018-49
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (3)

• weight

  weight in kilograms will be evaluate between birth and age (36 adjusted age SA)

  36 weeks

• height

  height in centimeters will be evaluate between birth and age (36 adjusted age SA)

  36 weeks

• head circumference

  head circumference in centimeters will be evaluate between birth and age (36 adjusted age SA)

  36 weeks

Study Arms (2)

nutrition not aggressive group

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 ")

aggressive nutrition group

Children will be grouped according to their calorie and protein during the first week of life. the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Children born prematurely between 30 WA (week of amenorrhea) and 32 WA + 6 days and included in the cohort EPIPAGE 2

You may qualify if:

• Children born prematurely between 30 WA (week of amenorrhea) and 32 WA + 6 days
• This will include 2,000 children meeting these criteria.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

ISABELLE GRANDVUILLEMIN, MD

CONTACT

+33 491373 432; Isabelle.GRANDVUILLEMIN@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 7, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

FR (1)