Persistent Pulmonary Hypertension of the Newborn - Mattel ...

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Off Label Drug Use• Off-label use of a drug should be:• based on sound evidence, expert medical judgment• done in good faith, in the best interest of the patient• discussed with the patient or parents• FDA encourages:• Publication of experience with off-label use of drugs• Report adverse events
Off Label Drug Use• New uses, doses, or indications will not beapproved by the FDA until substantial evidenceof safety and effectiveness – years, never??• Ethical & safety challenges• Neonates are constantly undergoing maturation –alter pharmacokinetics & end-organ responses• Therefore, clinical trials in adults or older childrencannot predict pharmacokinetics & end-organresponses of neonates
Page 7 and 8: It is 4 AM in the morning -------Yo
Page 9: Off Label Drug Use• FDA regulates
Page 13 and 14: Post-INO Era• Questionnaire to220
Page 16 and 17: Regulation of Pulmonary Vascular To
Page 18: Regulation of Pulmonary Vascular To
Page 21 and 22: PO Sildenafil• 1 st dose - 1 mg/0
Page 23 and 24: PDE-5 5 Inhibitor - Sildenafil• R
Page 25 and 26: PDE-5 5 Inhibitor - Sildenafil• P
Page 27 and 28: PDE-3 3 Inhibitor - Milrinone• Pr
Page 29 and 30: Milrinone Improves Oxygenationin Ne
Page 31 and 32: Regulation of Pulmonary Vascular To
Page 35: Regulation of Pulmonary Vascular To
Page 38 and 39: In utero exposure to PGSynthetase i
Page 40 and 41: Non-selective action:• Systemic &
Page 42 and 43: PGE 1 - Metabolism70-95%PGE 115-OH
Page 44 and 45: Studies of Inhaled Prostaglandins i
Page 46 and 47: Studies of Inhaled Prostaglandins i
Page 48 and 49: Phase I Clinical Trial of IPGE 1 in
Page 50 and 51: Phase I Trial: Dose ResponseDoseng/
Page 52 and 53: Phase I Trial: Adverse Effects:No e
Page 54 and 55: Effect on Ductus Arteriosus• Echo
Page 56 and 57: Stability and Emitted DoseModified
Page 58 and 59: ResultsLC-MS Chromatograms Followin
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Aerosol Particle Size DistributionA
Page 62 and 63:
Pharmacokinetics of IPGE 1 ?
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Nominal DoseAerosolizedRemain in de
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Aerosol Delivery Assessed by MRIExp
Page 68 and 69:
Aerosol Delivery Assessed by MRI450
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Aerosol Delivery During HFOVSood et
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Preliminary Data - Conclusions• P
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Specific AimsPrimary Aims:‣ Evalu
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Challenges: RCTs in PPHN• Small n
Page 79 and 80:
Thank YouDiscussion
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