Comparing the efficacy of inhaled versus infused milrinone in management of persistent pulmonary hypertension(PPHN) in infants

Comparison of the efficacy of inhaled and injectable milrinone in the treatment of PPHN

the parallel-group randomized trial, one-sided blinding, phase 3 on 32 patients, block randomization, randomization of blocks through random number table

Infants admitted to the NICU with PPHN are randomly divided into two groups, after considering inclusion and non-inclusion criteria. Demographic information, maternal underlying diseases, vital signs, and clinical findings are recorded in the checklist. Both groups receive an intravenous dopamine infusion, then the control and intervention groups receive intravenous milrinone and inhaled milrinone respectively، until the patient recovers or develops symptoms of respiratory distress or increased oxygen demand Echocardiography is repeated in the first 24 hours of hospitalization, 24 hours after the start of treatment, and when the infant shows signs of respiratory distress or increased oxygen demand (by a physician unaware of the treatment task). Rhythm, PR, intravascular pressure, urinary output, peripheral perfusion, and IV injection site are controlled. In the event of hypotension, arrhythmia, HR> 220, and thrombocytopenia, the infant is excluded from the study, and supportive measures are initiated for the infant.

entry: Infants 1 to 28 days with a diagnosis of PPHN; Hospitalized in NICU and indicated for treatment; Existence of conscious parental consent No entry: Neonates with congenital heart disorders, diaphragmatic hernias, pulmonary abnormalities; Infants are candidates for major surgery to eliminate abnormality

1: Dopamine + injectable milrinone 2: Dopamine + inhaled milrinone

Pulmonary artery pressure, Systemic artery pressure, Symptoms of respiratory distress, Oxygen supply index, Die or survive

Randomization with blocks, using binary blocks, Randomization of blocks using random number table. The intervention and control groups are called A and B, respectively, we prepare two series of blocks No. 1 (AB) and No. 2 (BA). Select a point in the table of random numbers at random and start moving in one direction. In each cell of the table, if the digit is an odd number, select block 1, and if it is even, selects block two, and place it in a row until 16 blocks selected (based on sample size). Then, each eligible patient who entered the study will be placed in the intervention or control group according to the order obtained.

The patient's echocardiography is performed by a different pediatrician who is unaware of the type of treatment intervention.