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Status unknownNCT03662503EPIPAGE2Updated Sep 7, 2018

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

An observational study in Premature Birth, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Birth

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03

In context

Premature Birth

2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 115 across 798 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Children with chromosomal abnormalities or malformations congenital
  • Children who died during the neonatal period
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. weight

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

    Time frame: 36 weeks

  2. height

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

    Time frame: 36 weeks

  3. head circumference

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

    Time frame: 36 weeks

07

Study locations

1 site
  • Assistance Publique Des Hopitaux de Marseille
    Marseille, PACA 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03662503
Responsible party
Sponsor
First posted
Sep 7, 2018
Start date
Dec 2018 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Jun 2021 (estimated)
Last update
Sep 7, 2018

Study contacts

ISABELLE GRANDVUILLEMIN, MD
Contact
Isabelle.GRANDVUILLEMIN@ap-hm.fr
+33 491373 432
EMILIE GARRIDO PRADALIE
study director · APHM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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