Clinical Trial: Early Protein Supplementation on Prevention of Hyperkalemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Early Protein Supplementation on Prevention of Hyperkalemia in Extremely Low Birth Weight Infants

Brief 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).

Detailed Summary:

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
Sponsor: The University of Texas Health Science Center at San Antonio

Current Primary Outcome: Incidence of hyperkalemia in between groups

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of hyperglycemia, post-natal growth, neurodevelopmental outcome at 18 months

Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center at San Antonio

Dates:
Date Received: February 8, 2006
Date Started: December 2002
Date Completion:
Last Updated: December 6, 2012
Last Verified: December 2012