Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290160
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2006-02-08
Brief Title:
Early Protein Supplementation on Prevention of Hyperkalemia
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
The Effect of Early Protein Supplementation on Prevention of Hyperkalemia in Extremely Low Birth Weight Infants
Status:
COMPLETED
Status Verified Date:
2023-10
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:
Evaluate if early protein supplementation decreases the incidence of hyperkalemia in Extremely Low Birth Weight Infants babies less than 1000 grams birth weight
Detailed Description:
Randomized double blind prospective clinical trial All infants admitted to University Hospital neonatal intensive care unit with birth weight of 1000 grams mmore than 24 weeks gestation and with no congenital anomalies will be enrolled in the study This will include inborn infants and those that are transported from outlying hospitals and admitted at 12 hours of life After informed consent infants will be randomized to receive either standard of care nutritional management or nutritional management per study protocol with the addition of protein supplementation Randomization will take place in the pharmacy
Control Group Infants enrolled in the control group will be started on intravenous fluids IVF on admission to the NICU with 5 Dextrose and 1500 mg calcium gluconate per 500 cc for a total fluid intake of either 120 or 150 cckgday The attending neonatologist in accordance with the infants gestational age and maturity will make the decision regarding total fluid intake The control group will be started at 05 gramkgd of protein Amynosin PF on DOL 1 and increase by 05 gramkgday every day to a maximum of 3 gramskgday
Study group The study group will receive the same total fluid intake 120 cckgday or 150 cckgday and 5 dextrose infusion with calcium gluconate and the addition of 2 gramskgday of protein Aminosyn PF The study group will receive 2 gramskgday of protein for 24 hours to 36 hours and will increase by 1 gramkgday up to a maximum of 4 gramskgday
In both groups caloric intake will start at 29-34 kcalkg day ie approximately 20-25 calories per kilogram from glucose and 9 calories per kilogram from lipids Caloric intake will be progressively increased depending on the infants tolerance to glucose Protein to glucose ratio in the control group will be 250-312 and nitrogen balance ratio including all calories will be approximately 362-425 In the study group protein to glucose ratio will be 64-80 and nitrogen balance ratio including all calories will be 93-109 The control group corresponds to the current standard of care The study group nitrogen balance is within the limits of recent studies which show that a nitrogen balance ratio of 46-78 is appropriate for ELBW infants
Glucose infusion rate GIR will be increased by attending neonatologist depending on infants glucose tolerance Usually GIR is started at 6 mgkgmin and increased by 1 milligram per kilo per minute every 24 hrs in ELBW infants For fluctuations in glucose adjustments in glucose infusion rate GIR will be via piggyback dextrose to the IVF if necessary
Lipids will be supplied as a 20 solution and will be started by attending neonatologist according to standard of care 05-1 grkg first day of life then increases of 05-1 grkg per day up to a maximum of 3 grkg day
All infants will be started on Total Parenteral Nutrition TPN on DOL 1 The amino acid solution Aminosyn PF will be supplemented with 40 mg cysteine hydrochloridekgday in both groups since it is considered to be one of the essential amino acids for premature infants Stable isotope studies have suggested improved protein retention with cysteine supplementation 3 The amino acid solution will be added via pharmacy per study protocol Subjects will continue to receive supplementation for the first week of life
Initiation of feedings TPN fluid and electrolyte intake will be determined by the attending neonatologist
If the infant develops hyperkalemia 65 mmollt treatment will be determined by attending neonatologist based on standard of care incluiding an increase in intravenous fluid delivery diuretic therapy lasix correction of acidosis close monitoring of ionized and total calcium levels and correction with calcium gluconate if needed glucose and insulin infusion kayexalate and if refractory exchange transfusion might be considered
Following completion of the study we will continue to monitor standard laboratory data including serum and urine electrolytes We will also monitor growth until hospital discharge Following discharge infants will be followed in PREMIEre clinic for neurodevelopmental outcome with Bayley testing at 6 12 and 18 months CGA In addition to the primary outcome reduction in incidence of hyperkalemia our secondary outcomes of interest include the incidence of hyperglycemia the incidence of periventricular-intraventricular hemorrhage PIVH renal function growth and neurodevelopmental outcome at 18 months corrected gestational age
Control Group Infants enrolled in the control group will be started on intravenous fluids IVF on admission to the NICU with 5 Dextrose and 1500 mg calcium gluconate per 500 cc for a total fluid intake of either 120 or 150 cckgday The attending neonatologist in accordance with the infants gestational age and maturity will make the decision regarding total fluid intake The control group will be started at 05 gramkgd of protein Amynosin PF on DOL 1 and increase by 05 gramkgday every day to a maximum of 3 gramskgday
Study group The study group will receive the same total fluid intake 120 cckgday or 150 cckgday and 5 dextrose infusion with calcium gluconate and the addition of 2 gramskgday of protein Aminosyn PF The study group will receive 2 gramskgday of protein for 24 hours to 36 hours and will increase by 1 gramkgday up to a maximum of 4 gramskgday
In both groups caloric intake will start at 29-34 kcalkg day ie approximately 20-25 calories per kilogram from glucose and 9 calories per kilogram from lipids Caloric intake will be progressively increased depending on the infants tolerance to glucose Protein to glucose ratio in the control group will be 250-312 and nitrogen balance ratio including all calories will be approximately 362-425 In the study group protein to glucose ratio will be 64-80 and nitrogen balance ratio including all calories will be 93-109 The control group corresponds to the current standard of care The study group nitrogen balance is within the limits of recent studies which show that a nitrogen balance ratio of 46-78 is appropriate for ELBW infants
Glucose infusion rate GIR will be increased by attending neonatologist depending on infants glucose tolerance Usually GIR is started at 6 mgkgmin and increased by 1 milligram per kilo per minute every 24 hrs in ELBW infants For fluctuations in glucose adjustments in glucose infusion rate GIR will be via piggyback dextrose to the IVF if necessary
Lipids will be supplied as a 20 solution and will be started by attending neonatologist according to standard of care 05-1 grkg first day of life then increases of 05-1 grkg per day up to a maximum of 3 grkg day
All infants will be started on Total Parenteral Nutrition TPN on DOL 1 The amino acid solution Aminosyn PF will be supplemented with 40 mg cysteine hydrochloridekgday in both groups since it is considered to be one of the essential amino acids for premature infants Stable isotope studies have suggested improved protein retention with cysteine supplementation 3 The amino acid solution will be added via pharmacy per study protocol Subjects will continue to receive supplementation for the first week of life
Initiation of feedings TPN fluid and electrolyte intake will be determined by the attending neonatologist
If the infant develops hyperkalemia 65 mmollt treatment will be determined by attending neonatologist based on standard of care incluiding an increase in intravenous fluid delivery diuretic therapy lasix correction of acidosis close monitoring of ionized and total calcium levels and correction with calcium gluconate if needed glucose and insulin infusion kayexalate and if refractory exchange transfusion might be considered
Following completion of the study we will continue to monitor standard laboratory data including serum and urine electrolytes We will also monitor growth until hospital discharge Following discharge infants will be followed in PREMIEre clinic for neurodevelopmental outcome with Bayley testing at 6 12 and 18 months CGA In addition to the primary outcome reduction in incidence of hyperkalemia our secondary outcomes of interest include the incidence of hyperglycemia the incidence of periventricular-intraventricular hemorrhage PIVH renal function growth and neurodevelopmental outcome at 18 months corrected gestational 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