Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196482
Status:
UNKNOWN
Last Update Posted:
2006-09-12
First Post:
2005-09-13
Brief Title:
Human Milk Fortifiers and Acid-Base Status
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants
Two different compositions are tested main difference is in electrolyte composiiton
Two different compositions are tested main difference is in electrolyte composiiton
Detailed Description:
Two groups each consisting of 15 infants with a birth weight below 2000g are studiedrandomization is startified by three birth weigth classes 1000g 1000-1500g1500 - 2000g human milk fortifier is introduced in two steps after oral feeding is achieved two acid-base status and electrolyte concentrations are measured when metabolic acidosis defined as BE -6 mmoll occurs fortifier feeding is stopped and after a wash-out period of three days the alternative product is usedagain occurence of metabolic acidosis need for oral bicarbonate and effect on longitudinal growth an weight gain are registered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None