Article Text

RENAL PHARMACOVIGILANCE AT 36 WEEKS CORRECTED GESTATIONAL AGE AMONG BABIES BORN <1500 G OR <32 WEEKS: A FEASIBILITY STUDY USING ROUTINELY COLLECTED DATA
  1. K Thattakkat1,
  2. M A Turner2
  1. 1Department of Paediatrics, Royal Liverpool Children’s NHS Trust, Mersey Deanery, Alder Hey, Liverpool, UK
  2. 2University of Liverpool, Liverpool Women’s Hospital Neonatal Unit, Liverpool, UK

Abstract

Objective The European Medicines Agency has recently stressed the importance of pharmacovigilance (PV) for preterm infants. We aimed to assess the feasibility of using routinely collected serum creatinine (SCr) measurements in neonatal PV, taking account of clinical circumstances.

Methods Details of all infants born <1500 g or <32 weeks admitted to our Regional Neonatal Unit in 2007 were extracted from the Unit database, including results of blood tests closest to 36 weeks corrected gestational age (36±7 days).

Results Of 155 eligible infants, SCr was available between 35 and 36+6 weeks for 52 (34%) – 16 had died, 76 were discharged or transferred before 35 weeks, and 26 inpatients did not have a blood test within the sampling period. Mean SCr was 36 μmol/L, SD 6.4, range 25 to 51. SCr was correlated with gestational age at birth (rs = 0.304, p<0.05) and was higher in infants on full enteral feeds at the time of sampling, median (IQR), 36 (32–42) than in those on IV fluids, 29 (27–33), p<0.01. SCr was neither associated with birth weight, CRIB score, days of ventilation or days exposed to gentamicin, nor to daily nutritional volume, weight or oxygen dependence at the time of sampling.

Conclusions Comprehensive neonatal PV involving SCr would require regional follow-up and blood sampling episodes that are not part of routine clinical practice. Since no infants had an abnormal value and SCr was associated with nutritional status, other markers of renal function may be more appropriate.

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