Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)

Summary

This pilot randomized clinical trial compares dopamine and norepinephrine as first-line vasoactive therapies in term and late preterm neonates with pulmonary hypertension associated with hypoxemic respiratory failure and systemic hypotension. Systemic hypotension is a common and clinically significant complication of persistent pulmonary hypertension of the newborn (PPHN) and frequently requires vasopressor support to maintain adequate systemic perfusion. Dopamine is commonly used in this setting; however, prior animal experimental and clinical data suggest it may increase pulmonary vascular resistance, potentially worsening right ventricular afterload and hypoxemia. Norepinephrine may preferentially increase systemic vascular resistance with less effect on the pulmonary circulation. This study evaluates short-term hemodynamic and oxygenation responses following initiation of dopamine or norepinephrine.

Timeline

Start

2026-06-30

Primary completion

2027-06-30

Completion

2027-06-30

Publications

• Background Jain A, El-Khuffash AF, van Herpen CH, Resende MHF, Giesinger RE, Weisz D, Mertens L, Jankov RP, McNamara PJ. Cardiac Function and Ventricular Interactions in Persistent Pulmonary Hypertension of the Newborn. Pediatr Crit Care Med. 2021 Feb 1;22(2):e145-e157. doi: 10.1097/PCC.0000000000002579.
• Background Lesneski AL, Vali P, Hardie ME, Lakshminrusimha S, Sankaran D. Randomized Trial of Oxygen Saturation Targets during and after Resuscitation and Reversal of Ductal Flow in an Ovine Model of Meconium Aspiration and Pulmonary Hypertension. Children (Basel). 2021 Jul 14;8(7):594. doi: 10.3390/children8070594.
• Background Siefkes HM, Lakshminrusimha S. Management of systemic hypotension in term infants with persistent pulmonary hypertension of the newborn: an illustrated review. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):446-455. doi: 10.1136/archdischild-2020-319705. Epub 2021 Jan 21.
• Background Lakshminrusimha S. The pulmonary circulation in neonatal respiratory failure. Clin Perinatol. 2012 Sep;39(3):655-83. doi: 10.1016/j.clp.2012.06.006.
• Background Tourneux P, Rakza T, Bouissou A, Krim G, Storme L. Pulmonary circulatory effects of norepinephrine in newborn infants with persistent pulmonary hypertension. J Pediatr. 2008 Sep;153(3):345-9. doi: 10.1016/j.jpeds.2008.03.007. Epub 2008 May 12.
• Background Steinhorn RH. Neonatal pulmonary hypertension. Pediatr Crit Care Med. 2010 Mar;11(2 Suppl):S79-84. doi: 10.1097/PCC.0b013e3181c76cdc.
• Background Sankaran D, Lakshminrusimha S. Pulmonary hypertension in the newborn- etiology and pathogenesis. Semin Fetal Neonatal Med. 2022 Aug;27(4):101381. doi: 10.1016/j.siny.2022.101381. Epub 2022 Aug 7.
• Background McNamara PJ, Giesinger RE, Lakshminrusimha S. Dopamine and Neonatal Pulmonary Hypertension-Pressing Need for a Better Pressor? J Pediatr. 2022 Jul;246:242-250. doi: 10.1016/j.jpeds.2022.03.022. Epub 2022 Mar 18. No abstract available.
• Background Liet JM, Boscher C, Gras-Leguen C, Gournay V, Debillon T, Roze JC. Dopamine effects on pulmonary artery pressure in hypotensive preterm infants with patent ductus arteriosus. J Pediatr. 2002 Mar;140(3):373-5. doi: 10.1067/mpd.2002.123100.
• Background Cheung PY, Barrington KJ. The effects of dopamine and epinephrine on hemodynamics and oxygen metabolism in hypoxic anesthetized piglets. Crit Care. 2001;5(3):158-66. doi: 10.1186/cc1016. Epub 2001 Apr 26.
• Background Budniok T, ElSayed Y, Louis D. Effect of Vasopressin on Systemic and Pulmonary Hemodynamics in Neonates. Am J Perinatol. 2021 Oct;38(12):1330-1334. doi: 10.1055/s-0040-1712999. Epub 2020 Jun 2.
• Background Shah S, Dhalait S, Fursule A, Khandare J, Kaul A. Use of Vasopressin as Rescue Therapy in Refractory Hypoxia and Refractory Systemic Hypotension in Term Neonates with Severe Persistent Pulmonary Hypertension-A Prospective Observational Study. Am J Perinatol. 2024 May;41(S 01):e886-e892. doi: 10.1055/a-1969-1119. Epub 2022 Oct 27.
• Background McNamara PJ, Jain A, El-Khuffash A, Giesinger R, Weisz D, Freud L, Levy PT, Bhombal S, de Boode W, Leone T, Richards B, Singh Y, Acevedo JM, Simpson J, Noori S, Lai WW. Guidelines and Recommendations for Targeted Neonatal Echocardiography and Cardiac Point-of-Care Ultrasound in the Neonatal Intensive Care Unit: An Update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2024 Feb;37(2):171-215. doi: 10.1016/j.echo.2023.11.016.
• Background de Boode WP, Singh Y, Gupta S, Austin T, Bohlin K, Dempsey E, Groves A, Eriksen BH, van Laere D, Molnar Z, Nestaas E, Rogerson S, Schubert U, Tissot C, van der Lee R, van Overmeire B, El-Khuffash A. Recommendations for neonatologist performed echocardiography in Europe: Consensus Statement endorsed by European Society for Paediatric Research (ESPR) and European Society for Neonatology (ESN). Pediatr Res. 2016 Oct;80(4):465-71. doi: 10.1038/pr.2016.126. Epub 2016 Jun 8. No abstract available.

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Indications