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OpenTrials
Completed

NCT Number: NCT03217045

Nutrition Protocol and Premature Infants' Growth

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.

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Key information

Conditions

Premature Infants Female Urogenital Diseases and Pregnancy Complications Growth Retardation Nutrition Deficiency Due to Insufficient Food Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–77 day

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Death
  • Any congenital malformation

Treatment and study plan

nutrition protocol introduction

Other

Growth comparison of 2 cohorts of infants evaluated in a before-after design

Primary outcomes

  1. weight

    Time frame: weekly recording from Day 0 up to Day 77

    longitudinal weight evaluation

Secondary outcomes

  1. Necrotizing enterocolitis

    Time frame: Day 77 postnatal age

    Necrotizing enterocolitis

  2. late onset sepsis

    Time frame: Day 77 postnatal age

    Incidence of late onset sepsis

  3. patent ductus arteriosus

    Time frame: Day 77 postnatal age

    Incidence of patent ductus aretriosus requiring treatment

  4. Bronchopulmonary dysplasia

    Time frame: Day 77 postnatal age

    Incidence of Bronchopulmonary dysplasia

  5. Central venous catheters.

    Time frame: Day 77 postnatal age

    Duration of central venous catheters

  6. Compliance to the protocol

    Time frame: weekly recording from Day 0 up to Day 77

    comparison between expected prescription and actual nutrition intake

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: Nutriproto

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Jul 13, 2017
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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