Nutrition Protocol and Premature Infants' Growth

Completed

• Conditions: Premature Infants; Nutrition Deficiency Due to Insufficient Food; Growth Retardation
• Interventions: Other: nutrition protocol introduction

• Registration Number: NCT03217045
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2014-10-31
• Study Completion: 2017-04-01
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Exclusion Criteria

• Death
• Any congenital malformation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Before Protocol	nutrition protocol introduction	72 premature infants born between 26 and 32 weeks gestation, over 6 months period, and involved before the introduction of a strict nutrition protocol
After Protocol	nutrition protocol introduction	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

Primary Outcome Measures

Name	Time	Method
weight	weekly recording from Day 0 up to Day 77	longitudinal weight evaluation

Secondary Outcome Measures

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