Status:
UNKNOWN
High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants
Lead Sponsor:
Università Politecnica delle Marche
Conditions:
Infant, Very Low Birth Weight
Eligibility:
All Genders
24-32 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, o...
Detailed Description
Increasing protein and energy intake above the anabolic capacity of a given individual may result in increased lipogenesis and excessive fat deposition. Adults with reduced mobility or with neuromuscu...
Eligibility Criteria
Inclusion
- 24 weeks \< gestational age \< 32 weeks
- inborn or outborn admitted before 24 hours of age
- parenteral or enteral nutrition start before 48 hours of age
- parental consent
Exclusion
- difficulty in starting physical activity stimulation before 10 days of life
- death before 36 W PMA
- diagnosis of necrotising enterocolitis (before 36 W PMA)
- any major surgery (before 36 W PMA)
- congenital syndrome, severe malformations
- inborn errors of metabolism
- parental consent withdrawn
Key Trial Info
Start Date :
April 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03374033
Start Date
April 10 2017
End Date
July 30 2022
Last Update
May 9 2019
Active Locations (1)
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1
Ospedale G. Salesi
Ancona, Italy, 60123