Nutrition Protocol and Premature Infants' Growth
Nutriproto
Impact of Introducing a Standardized Nutrition Protocol on Very Premature Infants' Growth and Morbidity
1 other identifier
observational
158
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedFebruary 15, 2023
February 1, 2023
1.5 years
July 12, 2017
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
weight
longitudinal weight evaluation
weekly recording from Day 0 up to Day 77
Secondary Outcomes (6)
Necrotizing enterocolitis
Day 77 postnatal age
late onset sepsis
Day 77 postnatal age
patent ductus arteriosus
Day 77 postnatal age
Bronchopulmonary dysplasia
Day 77 postnatal age
Central venous catheters.
Day 77 postnatal age
- +1 more secondary outcomes
Study Arms (2)
Before Protocol
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
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
Interventions
Growth comparison of 2 cohorts of infants evaluated in a before-after design
Eligibility Criteria
All infants born between 26 to 32 weeks gestation and admitted to our level III NICU were eligible and included in the study
You may qualify if:
- All surviving infants born between 26 and 32 weeks gestation in our Level III NICU
You may not qualify if:
- Death
- Any congenital malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wittwer A, Hascoet JM. Impact of introducing a standardized nutrition protocol on very premature infants' growth and morbidity. PLoS One. 2020 May 21;15(5):e0232659. doi: 10.1371/journal.pone.0232659. eCollection 2020.
PMID: 32437423DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 13, 2017
Study Start
May 1, 2013
Primary Completion
October 31, 2014
Study Completion
April 1, 2017
Last Updated
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share