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Study aim
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Considering the importance of prematurity and weight gain in long-term health outcomes, lack of an agreement on parenteral nutrition diets for Very Low Birth Weight (VLBW) neonates, and role of glucose in nutrition, this study investigates the effect of increasing calories by adding glucose intake on weight gain in premature neonates.
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Design
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A parallel-group, blinded, phase 3 clinical trial design of 82 patients who were divided into intervention and control groups sequentially.
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Settings and conduct
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The clinical trial will be conducted on VLBW neonates in Neonatal Intensive Care Unit (NICU) of Ali Asghar, Akbar Abadi, and FiroozAbadi from May to December 2020. All the neonates will receive Total Parenteral Nutrition (TPN). While neonates in the intervention group will intake 12.5% DW, those in the control group will intake 10% DW. Birth weight and neonate's weight in the fifth, seventh, tenth, and fifteenth days after birth will be recorded by a specific scale. We consider the length of hospitalization and the date on which the neonate will be released.
The daily calories intaken will be calculated based on TPN, serum volume (until neonate meet 150cc/kg), and breastfeed (if applies). The procedure will be continued until samples reach their birth weights, the duration that is used as the primary criterion for efficacy.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: one-to-thirty-day neonates with birth weights lower than 1500g
Exclusion criteria: Septic neonates, due to probable undesired interventions
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Intervention groups
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Neonates, who meet inclusion criteria, receive Total Parenteral Nutrition (TPN) and will intake 10% and 12.5% dextrose water (DW) serum. Then, we compare the weight gaining of neonates intaken 12.5% DW with those intaken 10% DW.
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Main outcome variables
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Birth weight; Days receiving TPN; Steroid before birth; Surfactant, Daily weight; Invasive ventilation duration