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. 2006 Oct 18;2006(4):CD004869. doi: 10.1002/14651858.CD004869.pub2

Storm 2003.

Methods Single site cross‐over randomized trial. Blinding of randomization: yes. Blinding of intervention: yes. Complete follow‐up: yes. Blinding of outcome measurement: yes.
Participants Total number of patients entered into the study: 18. Entry criteria: low birth weight premature infants, gestational age ranged 30‐37 weeks, postnatal age less than 4 weeks, requiring PN for at least two weeks. Exclusion criteria: inborn genetic error or significant organ failure.
Interventions After a 3‐day PN without cysteine, infants were randomly allocated to one of six successive schedules dosing schedules of cysteine hydrochloride for 3 days, ranging between 0 and 40 mg/g amino acids. For this systematic review we compared the levels of cyst(e)ine at the end of the schedule with the highest amount of cysteine intake (40 mg of cysteine hydrochloride per g of amino acid) (treatment, n = 18) versus the levels at the end of the lowest, i.e., 0 mg/g (control, n = 18).
Outcomes Plasma levels of taurine, cystine and methionine at the end of each successive schedule.
Notes Abstract only. Target PN dosage was 2.5 g/kg of amino acids with total caloric intake of 135 kcal/kg/day. 
 Setting: United States.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Single site cross‐over randomized trial 
 Blinding of randomization: yes
Allocation concealment? Low risk Blinding of randomization: yes
Blinding? 
 All outcomes Low risk Blinding of intervention: yes 
 Blinding of outcome measurement: yes
Incomplete outcome data addressed? 
 All outcomes Low risk Complete follow‐up: yes