Nutritional Deficiency, Very Low Birth Weight Infant
Conditions
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 mg/kg/day of elemental zinc. The main question it aims to answer: • Does an enteral Zinc supplement of 1 mg/kg/day 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 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive \ 1 mg/kg/day 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 patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day 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 mg/kg/day of elemental zinc. The main question it aims to answer: • Does an enteral Zinc supplement of 1 mg/kg/day 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 ml/kg/day 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 mg/kg/day 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 patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day 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.
Interventions
DRUGZinc Sulfate
The pharmacy will be the one preparing the Zinc sulfate. The zinc sulfate comes in 220 mg tablets which are then mixed with 1 ml of Oral plus (a common suspending agent) as well as 9 ml of Sterile water. This then makes a Zinc Sulfate 22 mg/ml oral suspension which will be dispensed in an amber syringe.
OTHERSterile Water
The placebo group with will receive a similar amount of sterile water in a colored syringe
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 36 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Birth weight \< 1500 grams 2. Infant is tolerating at least 100 ml/kg/day of enteral feeds 3. At least 25wks PMA.
Exclusion criteria
* Major congenital malformations especially anomaly of the GI tract * Major congenital heart disease (i.e.: ductal dependent lesion) * Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection * Infant who has tolerated ≥100 ml/kg/day prior to admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of weight gain | at hospital discharge or 36 weeks PMA whichever comes first. | The primary outcome would be the rate of weight gain in grams/kg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length | at hospital discharge of 36 weeks PMA whichever comes first | This secondary outcome would be the rate of length gain in cm/day |
| Head Circumference | at hospital discharge of 36 weeks PMA whichever comes first | This secondary outcome would be the rate of head circumference gain in cm/day |
| Zinc level | Comparing the initial zinc level to the four week zinc level as well as the zinc level at 36 weeks or discharge whichever comes first | This secondary outcome would be looking for a statically significant difference in zinc level |
Contacts
Primary ContactAndrew C Mire, M.D.
Backup ContactMark Weems, M.D.
Outcome results
None listed