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Neonatal Intensive Care Drug Manual
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| bet | 35/654 | | Sana | 03.01.2022 | | Hajmi | 1,5 Mb. | | #14803 |
Special Comments
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Evidence summary
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Efficacy
Hypotensive preterm infants: Two RCTs [3, 4] have compared volume expansion using albumin 5% to normal saline 10 mL/kg in hypotensive preterm infants. Meta-analysis [5] found no significant difference in mortality (typical RR 1.02; 95% CI 0.50, 2.06) or PIVH. No data were available for periventricular leukomalacia (PVL) or long-term disability. Meta-analysis found no significant difference in treatment failure (2 studies, 163 infants; typical RR 0.76, 95% CI 0.54, 1.07) although there was substantial heterogeneity between studies. There were no significant differences for other neonatal morbidities including BPD, PDA, NEC and sepsis. One trial [6] with 20 infants in each group with a systolic BP <40 mmHg compared fresh frozen plasma to albumin 4.5% 15 mL/kg and reported no difference in change in mean BP, although both these groups had a significantly greater increase in mean BP than a control group who received albumin 20% 5 mL/kg. Other outcomes were not reported. Systematic review concluded there is insufficient evidence to determine whether infants with cardiovascular compromise benefit from volume expansion or what type of volume expansion should be used in preterm infants (if at all) [5]. In addition, two RCTs [7, 8] have compared albumin 4.5% 15 to 20 mL/kg to dopamine in a total of 63 hypotensive preterm infants. Systematic review [9] found dopamine was more successful than albumin at correcting low BP in hypotensive preterm infants, but neither dopamine nor albumin improved blood flow, mortality or morbidity in preterm infants.
A systematic review of RCTs comparing albumin or PPF with no albumin or PPF or with a crystalloid solution in critically ill patients with hypovolaemia, burns or hypoalbuminaemia included 38 trials with 1,958 deaths among 10,842 participants [10]. Several trials were in newborn infants although no subgroup analysis was performed. Overall, for hypovolaemia there was no difference in death following albumin administration (RR 1.02, 95% CI 0.92 to 1.13). For burns, the relative risk was 2.93 (95% CI 1.28 to 6.72) and for hypoalbuminaemia the relative risk was 1.26 (95% CI 0.84 to 1.88).
Conclusion: Albumin solutions cannot be recommended as treatment for hypotension in newborn infants. [LOE I, GOR C]
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