Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00290160 |
| Other study ID # |
012-9000-400 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2002 |
| Est. completion date |
July 2007 |
Study information
| Verified date |
October 2023 |
| Source |
The University of Texas Health Science Center at San Antonio |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Evaluate if early protein supplementation decreases the incidence of hyperkalemia in
Extremely Low Birth Weight Infants (babies less than 1,000 grams birth weight).
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 cc/kg/day. The attending neonatologist in
accordance with the infant's gestational age and maturity will make the decision regarding
total fluid intake. The control group will be started at 0.5 gram/kg/d of protein ( Amynosin
PF) on DOL 1 and increase by 0.5 gram/kg/day every day to a maximum of 3 grams/kg/day.
Study group: The study group will receive the same total fluid intake (120 cc/kg/day or 150
cc/kg/day) and 5% dextrose infusion with calcium gluconate and the addition of 2 grams/kg/day
of protein (Aminosyn PF). The study group will receive 2 grams/kg/day of protein for 24 hours
to 36 hours and will increase by 1 gram/kg/day up to a maximum of 4 grams/kg/day.
In both groups, caloric intake will start at 29-34 kcal/kg day (i.e., approximately 20-25
calories per kilogram from glucose and 9 calories per kilogram from lipids). Caloric intake
will be progressively increased depending on the infant's 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
infant's glucose tolerance. Usually GIR is started at 6 mg/kg/min 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 (0.5-1 gr/kg first day of life, then increases of 0.5-1 gr/kg
per day up to a maximum of 3 gr/kg 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 hydrochloride/kg/day 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 (>6.5 mmol/lt), 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.
