What is the clinical evidence from this study?

Population: Persistent pulmonary hypertension of the newborn (n=11). Intervention: Milrinone. Primary outcome: Pharmacological profile of milrinone (half-life, clearance, volume of distribution, steady state concentration).

What question did this study set out to answer?

To characterize the pharmacokinetic profile, safety, and short-term clinical outcomes of intravenous milrinone in neonates with persistent pulmonary hypertension who exhibit a suboptimal response to inhaled nitric oxide.

November 6, 2012Pediatric Critical Care Medicine

Pharmacology of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn and Suboptimal Response to Inhaled Nitric Oxide*

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Key result

Intravenous milrinone in neonates with persistent pulmonary hypertension improved PaO2 (p=0.002) and reduced FIO2 (p<0.001), with a mean half-life of 4.1 hours.

Why the study?

Does milrinone improve oxygenation and hemodynamics in neonates with persistent pulmonary hypertension of the newborn and suboptimal response to inhaled nitric oxide?

Key Points

To characterize the pharmacokinetic profile, safety, and short-term clinical outcomes of intravenous milrinone in neonates with persistent pulmonary hypertension who exhibit a suboptimal response to inhaled nitric oxide.
Conducted an open-label pharmacokinetic and pharmacodynamic study in 11 neonates (gestational age 39.2 ± 1.3 weeks, birth weight 3481 ± 603 g) with persistent pulmonary hypertension of the newborn.
Administered an intravenous loading dose of milrinone at 50 μg/kg over 60 minutes, followed by a continuous maintenance infusion of 0.33 to 0.99 μg/kg/min for 24 to 72 hours.
Assessed serial serum milrinone concentrations, cardiorespiratory parameters, inotrope requirements, and serial echocardiographic indices before and at 1 and 12 hours after drug initiation.
Pharmacokinetic analysis demonstrated a mean elimination half-life of 4.1 ± 1.1 hours, clearance of 0.11 ± 0.01 L/kg/hr, volume of distribution of 0.56 ± 0.19 L/kg, and steady-state concentration of 290.9 ± 77.7 ng/mL.
Milrinone initiation significantly improved arterial PaO2 (p = 0.002) and achieved sustained reductions in FiO2 (p < 0.001), oxygenation index (p < 0.001), mean airway pressure (p = 0.03), and inhaled nitric oxide dosage (p < 0.001).
Despite a transient decrease in systolic arterial pressure post-bolus (p < 0.001), therapy significantly improved base deficit (p = 0.01), plasma lactate (p = 0.04), pulmonary artery pressure, and biventricular output while reducing right-to-left shunting (p < 0.05).

Structured PICO

Does milrinone improve oxygenation and hemodynamics in neonates with persistent pulmonary hypertension of the newborn and suboptimal response to inhaled nitric oxide?

Population

11 neonates with persistent pulmonary hypertension of the newborn and suboptimal response to inhaled nitric oxide treated with milrinone.

Intervention

Milrinone intravenous loading dose (50 μg/kg) over 60 mins followed by a maintenance infusion (0.33-0.99 μg/kg/min) for 24-72 hrs.

Outcome

Pharmacological profile of milrinone (pharmacokinetics)surrogate

Intravenous milrinone improves oxygenation and pulmonary hemodynamics in neonates with persistent pulmonary hypertension who have a suboptimal response to inhaled nitric oxide, supporting the need for further randomized trials.

Discussion

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Implication

Should not change practice in iNO-refractory PPHN; hypothesis-generating for adjunctive milrinone pending randomized trials.

Cite This Study

McNamara et al. (2012) studied Persistent pulmonary hypertension of the newborn (n=11). Milrinone was evaluated on Pharmacological profile of milrinone (half-life, clearance, volume of distribution, steady state concentration). Intravenous milrinone in neonates with persistent pulmonary hypertension improved PaO2 (p=0.002) and reduced FIO2 (p<0.001), with a mean half-life of 4.1 hours.

synapsesocial.com/papers/6a99681e2beb1e1a0778efa5 https://doi.org/10.1097/pcc.0b013e31824ea2cd

Topics

Echocardiography

View Full Paper

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Pharmacology of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn and Suboptimal Response to Inhaled Nitric Oxide*

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Topics

Pharmacology of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn and Suboptimal Response to Inhaled Nitric Oxide*

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider