| Methods |
Single‐site randomized trial. Blinding of allocation: can't tell. Blinding of intervention: can't tell. Complete follow‐up : yes. Blinding of outcome measurement: can't tell. |
| Participants |
Total number of patients entered into the study: 20. Entry criteria: preterm infants at least 2 days old, unable to take enteral feeds and unlikely to begin enteral feeding within 5‐7 days; or without enteral intake for 48 hours and would be unable to tolerate enteral feeds for at least 5‐7 days. Birthweight ranged between 900 g and 2500 g, and postnatal age between 3 and 53 days; gestational age is not provided. |
| Interventions |
Cysteine‐chloride (Abbott Laboratories) (72 mg/kg/day or 0.46 millimoles/kg/day) added to the parental solution for 6 days (n=10) versus no cysteine supplementation (n=10). |
| Outcomes |
Weight gain (no SD provided), nitrogen retention, plasma levels of total and free cysteine. |
| Notes |
Randomization stratified by nitrogen intake: those receiving low nitrogen intake (1.5 g/kg/day of amino acids) and those receiving high nitrogen intake (2.5 g/kg/day of amino acids). Amino acids: provided by Aminosyn (Abbott Laboratories), which contains neither cysteine, nor tyrosine in any form. Non protein calories ranged between 63 and 73 kcal/kg/day.
Setting: United States. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Single‐site randomized trial. Blinding of allocation: can't tell |
| Allocation concealment? |
Unclear risk |
Single‐site randomized trial. Blinding of allocation: can't tell |
| Blinding?
All outcomes |
Unclear risk |
Blinding of intervention: can't tell
Blinding of outcome measurement: can't tell |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Complete follow‐up : yes |
