Therapeutic strategies, including a high surgical ligation rate: Metods (part 3)

22 Jul
2012

Outcomes
The primary outcome of the study was the rate of duct ligation in infants receiving more than one course of indomethacin. The secondary outcome objective was to compare the occurrence of morbidity among infants in three groups: infants who, after one course of indomethacin, received ligation (with or without more indomethacin); just further indomethacin; or no further treatment at all. Also, to account for the potential deleterious effects of more than one course of indomethacin and a delay in surgical ligation, it was investigated whether there was a clinically significant difference in relevant outcomes between infants receiving more than one course of indomethacin compared with only one course of indomethacin, before surgical ligation.The morbidity outcome variables included NEC, severe renal dysfunction, CLD, time on mechanical ventilation, discharge home on oxygen and severe retinopathy of prematurity. Demographic information included the use of inotropes as a potential marker for hemodynamic dysfunction from the PDA.

Sample size

There are approximately 50 infants admitted per year to the Ottawa Hospital General Campus NICU and 15 infants admitted per year to the Children’s Hospital of Eastern Ontario NICU who are between the gestational ages of 23+0 to 26+6 weeks. Assuming a 20% early (ie, <7 days) mortality rate in these 65 infants, an 80% rate of PDA diagnosis and a subsequent treatment rate of 60%, approximately 25 infants per year will receive treatment for a PDA. The PDA will be unresponsive to the first course of indomethacin in 33% to 66% of cases , and up to 32% may receive a second course of indomethacin. Therefore, it was estimated that approximately nine of the 25 infants with a PDA would receive a second course of indomethacin. Best quality drugs cheap: find cheap viagra online and discover best deals online.

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