Abstract
Twenty term/near term neonates with hypoxemic respiratory failure and oxygenation index ≥20 were enrolled in a Phase I/II feasibility, safety and dose escalation study of inhaled PGE1 (IPGE1). Incremental doses of IPGE1, delivered by a jet nebulizer over a 2-h period, followed by weaning over 1 h, were given to 13 patients before receiving inhaled nitric oxide (INO) (Group I), and to seven patients, who failed to respond to INO (Group II). Response was defined as an increase in PaO2 of either ≥ 25 (full) or 10–25 (partial) torr. Exit criteria included an acute deterioration in oxygenation status, a persistent oxygenation index above 35 in Group I, or the availability of extracorporeal membrane oxygenation (ECMO) in Group II. The mean (SD) increase in PaO2 at the end of IPGE1 administration was 63 (62.3) in Group I (p = 0.024), and 40 (62.1) in Group II (p > 0.05). In Group I, 8 of 13 neonates had a full response, but 4 deteriorated following discontinuation of IPGE1. Of these four, two responded to INO and two were placed on ECMO. Five patients deteriorated before or during IPGE1, and none of them responded to INO. In Group II, three of seven patients had a full response to IPGE1. One patient with a partial response and all patients exiting before or during IPGE1 administration were placed on ECMO. The results of our study indicate that IPGE1 may be a safe, selective pulmonary vasodilator in neonatal hypoxemic respiratory failure.
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Abbreviations
- BPD:
-
bronchopulmonary dysplasia
- ECMO:
-
extracorporeal membrane oxygenation
- HUS:
-
head ultrasound
- INO:
-
inhaled nitric oxide
- IPCKD:
-
infantile polycystic kidney disease
- IPGE1:
-
inhaled Prostaglandin E1
- MRI:
-
magnetic resonance imaging
- OI:
-
oxygenation index
- PaO2:
-
arterial oxygen tension
- PG:
-
prostaglandin
- PGE1:
-
prostaglandin E1
- PGI2:
-
prostaglandin I2
- PPHN:
-
persistent pulmonary hypertension of the newborn
- PVL:
-
periventricular leukomalacia
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This research was funded by Grant 1 K23 HD41423–01 from the National Institute of Child and Human Development and supported by grants from the Sarnaik Endowment Fund, Children's Research Center of Michigan.The results reported in this manuscript were presented in part at the Pediatric Academic Societies' Annual Meeting on May 5, 2003 at Seattle, WA.Nebulizers were provided courtesy of Westmed, Inc., for part of the study.
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Sood, B., Delaney-Black, V., Aranda, J. et al. Aerosolized PGE1: A Selective Pulmonary Vasodilator in Neonatal Hypoxemic Respiratory Failure Results of a Phase I/II Open Label Clinical Trial. Pediatr Res 56, 579–585 (2004). https://doi.org/10.1203/01.PDR.0000139927.86617.B6
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DOI: https://doi.org/10.1203/01.PDR.0000139927.86617.B6
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