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Clinical Trials/NCT03217045
NCT03217045
Completed
Not Applicable

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

Central Hospital, Nancy, France0 sites158 target enrollmentMay 1, 2013
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ConditionsPremature InfantsNutrition Deficiency Due to Insufficient FoodGrowth Retardation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Infants
Sponsor
Central Hospital, Nancy, France
Enrollment
158
Primary Endpoint
weight
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2013
End Date
April 1, 2017
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Any congenital malformation

Outcomes

Primary Outcomes

weight

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

longitudinal weight evaluation

Secondary Outcomes

  • late onset sepsis(Day 77 postnatal age)
  • Central venous catheters.(Day 77 postnatal age)
  • Compliance to the protocol(weekly recording from Day 0 up to Day 77)
  • Necrotizing enterocolitis(Day 77 postnatal age)
  • patent ductus arteriosus(Day 77 postnatal age)
  • Bronchopulmonary dysplasia(Day 77 postnatal age)

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