Effect of Sildenafil on the clinical course of newborns with transient tachypnea of newborns, A Clinical Trial

Evaluation the effect of Sildenafil on the clinical course of newborns with transient tachypnea of newborns.

This study was a double-blind, placebo-controlled trial in which 80 neonates with gestational age of 34 to 41 weeks of gestational age were diagnosed with TTN, 40 of them in the intervention group and 40 in the control group. Due to the lack of a similar study in the past, 20 neonates were entered into a pilot and based on their results, the sample size was calculated.

A study was conducted in Ahvaz Imam Khomeini Hospital's Neonatal Department. Correction was designed to reduce the likelihood of information bias, both patients and the assessor and the person analyzing the treatment outcomes, the type of treatment assigned to each individual, and Which group of patients were kept unaware.

Infants born at the gestational age of 34 weeks to 41 weeks of gestation and diagnosed with TTN were included in the study. Neonates with meconium aspiration, respiratory distress syndrome, pneumonia and congenital heart disease, toxic hypoxia, persistent hypoglycemia and polycythemia, Congenital anomaly, proven systemic infection (positive blood culture), intrauterine growth retardation, and history of fetal distress, multiple organ failure (MODS) were eliminated.

The newborns were randomly assigned into two groups receiving sildenafil and placebo (5% dextrose). In the intervention group, sildenafil was given as mg / kg 1 every 8 hours with a gavage tube, the first dose was administered immediately after admission. In the second group, placebo was prescribed. Sildenafil was prepared as a white powder in 5% dextrose at a concentration of 1 mg / ml. Both sildenafil solution in dextrose and placebo were stained in vials of the same form.

Need for mechanical ventilation

The newborns were randomly assigned into two groups receiving sildenafil and placebo (5% dextrose). In the intervention group, 40 sildenafil infants received 1 mg / kg every 8 hours with a gavage tube, the first dose was administered immediately after admission. In the second group, 40 newborns were given placebo. Physicians and nurses responsible for treating the contents of the vials were unaware.

To reduce the risk of bias, patients and assessor and statistician were blinded to know the type of treatment assigned to reach person and that which patient was in which group.