Background: Intravenous albumin infusion to treat hypoalbuminaemia is used in intensive care nurseries. Hypoalbuminaemia occurs in a number of clinical situations including prematurity, the acutely unwell infant, respiratory distress syndrome (RDS), chronic lung disease (CLD), necrotising enterocolitis (NEC), intracranial haemorrhage, hydrops fetalis and oedema. Fluid overload is a potential side effect of albumin administration. Albumin is a blood product and therefore carries the potential risk of infection and adverse reactions. Albumin is also a scarce and expensive resource.
Objectives: The primary objective was to assess whether albumin infusions, in preterm neonates with low serum albumin, reduces mortality and morbidity. A secondary objective was to assess whether albumin infusion is associated with significant side effects.
Search strategy: Searches were made of MEDLINE from 1966 to April 2004, CINAHL from 1982 to April 2004 and the current Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library issue 1, 2004). Previous reviews (including cross references) and abstracts were also searched.
Selection criteria: All randomised controlled trials in which individual patients were allocated to albumin infusion versus control were included. Cross-over studies were excluded. Quasi randomised trials were excluded. Participants were preterm infants who had hypoalbuminaemia. Types of interventions included albumin infusion versus placebo (e.g. crystalloid) or no treatment.
Data collection and analysis: The reviewers worked independently to search for trials for inclusion and to assess methodological quality. Studies were assessed using the following key criteria: blinding of randomisation, blinding of intervention, completeness of follow up and blinding of outcome measurement.
Main results: Only two small studies were found for inclusion in this review and only one reported clinically relevant outcomes - it found no significant differences for our primary outcome measure of death (RR 1.5 [95% confidence interval 0.3 - 7.43]) or secondary outcome measures of intraventricular haemorrhage, patent ductus arteriosus, necrotising enterocolitis, bronchopulmonary dysplasia, duration of mechanical ventilation and duration of oxygen therapy.
Reviewers' conclusions: There is a lack of evidence from randomised trials to determine whether the routine use of albumin infusion, in preterm neonates with low serum albumin, reduces mortality or morbidity, and no evidence to assess whether albumin infusion is associated with significant side effects. There is a need for good quality, double-blind randomised controlled trials to assess the safety and efficacy of albumin infusions in preterm neonates with low serum albumin.