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A randomized control trial of phototherapy and 20% albumin versus phototherapy and saline in Kilifi, Kenya.

Dorcas N MagaiMichael MwanikiAmina AbubakarShebe MohammedAnne L GordonRaphael KaluPaul MwangiHans M KootCharles R J C Newton
Published in: BMC research notes (2019)
One hundred and eighteen neonates were randomly assigned to phototherapy and 20% albumin (n = 59) and phototherapy and saline (n = 69). The median age at admission was 5 (interquartile range (IQR) 3-6) days, and the median gestation was 36 (IQR 36-38) weeks. No significant differences were found in the change in TSB (Mann-Whitney U =609, p = 0.98) and rate of change in TSB per hour after treatment (Mann-Whitney U = 540, p = 0.39) between the two groups. There were no significant differences between the two groups in the proportion of participants who required exchange transfusion (χ2 (2) = 0.36, p = 0.546); repeat phototherapy (χ2 (2) = 2.37, p = 0.123); and those who died (χ2 (2) = 0.92, p = 0.337). Trial registration The trial was registered in the International Standardized Randomized Controlled Trial Number (ISRCTN); trial registration number ISRCTN89732754.
Keyphrases
  • study protocol
  • randomized controlled trial
  • phase iii
  • phase ii
  • clinical trial
  • emergency department
  • blood pressure
  • preterm infants
  • gestational age
  • systematic review
  • low birth weight
  • acute kidney injury