Nutritional Care and Head Growth in Preterm Infants
KARLY
Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.
1 other identifier
observational
71
1 country
1
Brief Summary
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge. By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2016
1 active site
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
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedAugust 17, 2018
August 1, 2018
5 months
August 14, 2018
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight gain during hospitalization
difference in weight between birth and discharge
between birth and 40 weeks
Secondary Outcomes (2)
Crown-heel length gain during hospitalization
between birth and 40 weeks
Head circumference gain during hospitalization
between birth and 40 weeks
Study Arms (2)
Group A
Infants born in Lyon (France)
Group B
Infants born in Stockholm (Sweden)
Eligibility Criteria
Extremely low birth weight infants born in two European tertiary care centres: neonatal unit of Croix Rousse Hospital in Lyon, France and the neonatal unit of Astrid Lindgren Children's Hospital in Stockholm, Sweden
You may qualify if:
- birth weight under 1000 grams
- gestational age (GA) between 23 and 28 weeks
- born in 2012
- admitted during the first 24 hours of life
- stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death.
You may not qualify if:
- Neonates with congenital anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital de la croix rousse
Lyon, 69004, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jean-charles picaud, MD, PhD
Hopital de la croix rousse
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of pediatrics
Study Record Dates
First Submitted
August 14, 2018
First Posted
August 17, 2018
Study Start
December 1, 2016
Primary Completion
May 1, 2017
Study Completion
July 1, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08