Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433674
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-23
Brief Title:
Enteral Zinc Supplementation in Very Low Birth Weight Infants
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Enteral Zinc Supplementation in Very Low Birth Weight Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight VLBW infants by adding an enteral Zinc supplement of 1 mgkgday of elemental zinc The main question it aims to answer
Does an enteral Zinc supplement of 1 mgkgday increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
Once the participants have reached 100 mlkgday of enteral feeds The participants will be randomized to one of two groups The treatment group will receive 1 mgkgday of elemental enteral Zinc and the control group to receive similar amount of enteral sterile water put in a colored syringe The Zinc Supplement would be Zinc Sulfate The primary team would otherwise be managing the patients feeding using our hospitals feeding protocol As long as the patient is tolerating 100 mlkgday of enteral feeds the Zinc Supplement will continue until 36 weeks postmenstrual age PMA or hospital discharge whichever comes first
The participants will have three Zinc levels measured once prior to Zinc Supplementation once at around the four week mark and once at the completion of therapy
Does an enteral Zinc supplement of 1 mgkgday increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
Once the participants have reached 100 mlkgday of enteral feeds The participants will be randomized to one of two groups The treatment group will receive 1 mgkgday of elemental enteral Zinc and the control group to receive similar amount of enteral sterile water put in a colored syringe The Zinc Supplement would be Zinc Sulfate The primary team would otherwise be managing the patients feeding using our hospitals feeding protocol As long as the patient is tolerating 100 mlkgday of enteral feeds the Zinc Supplement will continue until 36 weeks postmenstrual age PMA or hospital discharge whichever comes first
The participants will have three Zinc levels measured once prior to Zinc Supplementation once at around the four week mark and once at the completion of therapy
Detailed Description:
This is a prospective single center randomized double blinded placebo controlled clinical trial The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mgkgday of elemental zinc The main question it aims to answer
Does an enteral Zinc supplement of 1 mgkgday increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
Once the participants have reached 100 mlkgday of enteral feeds The participants will be randomized using sealed envelopes The subjects will be randomly selected to one of two groups The treatment group will receive 1 mgkgday of elemental enteral Zinc and the control group to receive similar amount of enteral sterile water put in a colored syringe The Zinc Supplement would be Zinc Sulfate Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo The primary team would otherwise be managing the patients feeding using our hospitals feeding protocol As long as the patient is tolerating 100 mlkgday of enteral feeds the Zinc Supplement will continue until 36 weeks PMA or hospital discharge whichever comes first
The participants will have three Zinc levels measured once prior to Zinc Supplementation once at around the four week mark and once at the completion of therapy
Does an enteral Zinc supplement of 1 mgkgday increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
Once the participants have reached 100 mlkgday of enteral feeds The participants will be randomized using sealed envelopes The subjects will be randomly selected to one of two groups The treatment group will receive 1 mgkgday of elemental enteral Zinc and the control group to receive similar amount of enteral sterile water put in a colored syringe The Zinc Supplement would be Zinc Sulfate Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo The primary team would otherwise be managing the patients feeding using our hospitals feeding protocol As long as the patient is tolerating 100 mlkgday of enteral feeds the Zinc Supplement will continue until 36 weeks PMA or hospital discharge whichever comes first
The participants will have three Zinc levels measured once prior to Zinc Supplementation once at around the four week mark and once at the completion of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None