Nutrition Protocol and Premature Infants' Growth

Premature Infants Clinical Trial

— Nutriproto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217045
• Other study ID #: R2015-1
• Status: Completed
• Start date: May 1, 2013
• Est. completion date: April 1, 2017

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 1, 2017
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 77 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Death
• Any congenital malformation

Related Conditions & MeSH terms

• Growth Retardation
• Nutrition Deficiency Due to Insufficient Food
• Premature Birth
• Premature Infants

Intervention

Other:
• nutrition protocol introduction
Growth comparison of 2 cohorts of infants evaluated in a before-after design

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	longitudinal weight evaluation	weekly recording from Day 0 up to Day 77
Secondary	Necrotizing enterocolitis	Necrotizing enterocolitis	Day 77 postnatal age
Secondary	late onset sepsis	Incidence of late onset sepsis	Day 77 postnatal age
Secondary	patent ductus arteriosus	Incidence of patent ductus aretriosus requiring treatment	Day 77 postnatal age
Secondary	Bronchopulmonary dysplasia	Incidence of Bronchopulmonary dysplasia	Day 77 postnatal age
Secondary	Central venous catheters.	Duration of central venous catheters	Day 77 postnatal age
Secondary	Compliance to the protocol	comparison between expected prescription and actual nutrition intake	weekly recording from Day 0 up to Day 77