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Nutrition Protocol and Premature Infants' Growth

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03217045
Acronym
Nutriproto
Enrollment
158
Registered
2017-07-13
Start date
2013-05-01
Completion date
2017-04-01
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Retardation, Nutrition Deficiency Due to Insufficient Food, Premature Infants

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.

Interventions

OTHERnutrition protocol introduction

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 77 Days
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Death * Any congenital malformation

Design outcomes

Primary

MeasureTime frameDescription
weightweekly recording from Day 0 up to Day 77longitudinal weight evaluation

Secondary

MeasureTime frameDescription
late onset sepsisDay 77 postnatal ageIncidence of late onset sepsis
patent ductus arteriosusDay 77 postnatal ageIncidence of patent ductus aretriosus requiring treatment
Necrotizing enterocolitisDay 77 postnatal ageNecrotizing enterocolitis
Central venous catheters.Day 77 postnatal ageDuration of central venous catheters
Compliance to the protocolweekly recording from Day 0 up to Day 77comparison between expected prescription and actual nutrition intake
Bronchopulmonary dysplasiaDay 77 postnatal ageIncidence of Bronchopulmonary dysplasia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026