Nutrition Protocol and Premature Infants' Growth (Nutriproto)

February 13, 2023 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

Impact of Introducing a Standardized Nutrition Protocol on Very Premature Infants' Growth and Morbidity

Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes.

This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants born between 26 to 32 weeks gestation and admitted to our level III NICU were eligible and included in the study

Description

Inclusion Criteria:

  • All surviving infants born between 26 and 32 weeks gestation in our Level III NICU

Exclusion Criteria:

  • Death
  • Any congenital malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Before Protocol
72 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved before the introduction of a strict nutrition protocol
Other: nutrition protocol introduction
Growth comparison of 2 cohorts of infants evaluated in a before-after design
After Protocol
86 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved after the introduction of a strict nutrition protocol and a washout period of 6 months
Other: nutrition protocol introduction
Growth comparison of 2 cohorts of infants evaluated in a before-after design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: weekly recording from Day 0 up to Day 77
longitudinal weight evaluation
weekly recording from Day 0 up to Day 77

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Necrotizing enterocolitis
Time Frame: Day 77 postnatal age
Necrotizing enterocolitis
Day 77 postnatal age
late onset sepsis
Time Frame: Day 77 postnatal age
Incidence of late onset sepsis
Day 77 postnatal age
patent ductus arteriosus
Time Frame: Day 77 postnatal age
Incidence of patent ductus aretriosus requiring treatment
Day 77 postnatal age
Bronchopulmonary dysplasia
Time Frame: Day 77 postnatal age
Incidence of Bronchopulmonary dysplasia
Day 77 postnatal age
Central venous catheters.
Time Frame: Day 77 postnatal age
Duration of central venous catheters
Day 77 postnatal age
Compliance to the protocol
Time Frame: weekly recording from Day 0 up to Day 77
comparison between expected prescription and actual nutrition intake
weekly recording from Day 0 up to Day 77

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

October 31, 2014

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2015-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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