Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-14 @ 2:55 AM
Study NCT ID:
NCT02731092
Status:
UNKNOWN
Last Update Posted:
2016-04-19
First Post:
2016-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
Status:
UNKNOWN
Status Verified Date:
2016-04
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:
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
Detailed Description:
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
1. Lactoferrin related adverse events and serious adverse events
2. Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
1. Examine lactoferrin levels in saliva, urine, plasma and stool
2. Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
1. Lactoferrin related adverse events and serious adverse events
2. Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
1. Examine lactoferrin levels in saliva, urine, plasma and stool
2. Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
Study Oversight
Has Oversight DMC:
True
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?: