Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005775
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2000-06-01
Brief Title:
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight ELBW Infants
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
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:
Glutamine
Brief Summary:
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight ELBW less than or equal to 1000 gm infants Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings
Detailed Description:
Meeting the protein and energy requirements of extremely premature infants in early postnatal life requires early hyperalimentation and the gradual introduction of enteral feedings Glutamine which is the most abundant amino acid in the human body and taken up in greatest quantity by the fetus from the placenta is not routinely provided in neonatal parenteral nutrition preparations
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight ELBW less than or equal to 1000 gm infants Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings
Infants received a neurodevelopmental assessment by masked certified examiners at 18-22 months postmenstrual age
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight ELBW less than or equal to 1000 gm infants Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings
Infants received a neurodevelopmental assessment by masked certified examiners at 18-22 months postmenstrual age
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR001032 | NIH | None | httpsreporternihgovquickSearchM01RR001032 |
| U10HD027856 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD034167 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD021415 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD027881 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U01HD036790 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR000070 | NIH | None | None |