Efficacy of milrinone plus sildenafil in the treatment of neonates with persistent pulmonary hypertension: A single center, randomized controlled trial from a resource limited setting.

Authors

  • Muhammad Awais Roomi The Children’s Hospital and Institute of Child Health, Multan, Pakistan.
  • Abdur Rehman Malik The Children’s Hospital and Institute of Child Health, Multan, Pakistan.
  • Rana Tashfeen Arshad The Children’s Hospital and Institute of Child Health, Multan, Pakistan.
  • Muhammad Zahid The Children’s Hospital and Institute of Child Health, Multan, Pakistan.
  • Muhammad Sohail Arshad The Children’s Hospital and Institute of Child Health, Multan, Pakistan.

DOI:

https://doi.org/10.29309/TPMJ/2025.32.03.8823

Keywords:

Milrinone, Mortality, Oxygen Saturation, Pulmonary Hypertension, Sildenafil

Abstract

Objective: To compare the outcomes of milrinone plus sildenafil versus sildenafil alone in the treatment of persistent pulmonary hypertension (PPH) in neonates. Study Design: Randomized Controlled Trial. Setting: Department of Neonatology, The Children’s Hospital and Institute of Child Health, Multan, Pakistan. Period: December 2023 to May 2024.  Methods: A total of 42 neonates, diagnosed to have PPH were enrolled. Neonates were randomized to either oral sildenafil monotherapy (n=21) or oral sildenafil and intravenous (IV) milrinone (n=21). Primary outcome was decrease in pulmonary artery systolic pressure (PASP). Secondary outcomes were improvement in oxygen saturation, duration of hospitalization, treatment related side effects, and mortality. Results: In a total of 42 neonates, 25 (59.5%) were boys. The mean age at the time of enrollment was 9.63±3.51 days. The mean PASP at the time of enrollment was 55.73±7.91 mmHg. PASP was statistically similar at baseline (p=0.5512), and day-3 (p=0.2163). At day-7, PASP was significantly reduced in sildenafil plus milrinone group was reported in comparison sildenafil group (37.62±8.04 mmHg vs. 42.92±8.25 mmHg, p=0.0413). SPO2, mortality, and post-treatment complications were statistically similar among neonates of both study groups. The duration of hospitalization was significantly less among neonates of sildenafil plus milrinone group vs. sildenafil group (13.58±2.93 days vs. 16.82±4.24 days, p=0.0063). Conclusion: Combined oral sildenafil and IV milrinone was more efficacious than sildenafil alone in reducing pulmonary arterial pressure.

Author Biographies

Muhammad Awais Roomi, The Children’s Hospital and Institute of Child Health, Multan, Pakistan.

FCPS (Pediatric Medicine), Clinical Fellow Neonatology, 

Abdur Rehman Malik, The Children’s Hospital and Institute of Child Health, Multan, Pakistan.

FCPS (Neonatology), FCPS (Pediatric Medicine), Assistant Professor Neonatology, 

Rana Tashfeen Arshad, The Children’s Hospital and Institute of Child Health, Multan, Pakistan.

FCPS (Pediatric Medicine), Clinical Fellow Neonatology, 

Muhammad Zahid, The Children’s Hospital and Institute of Child Health, Multan, Pakistan.

FCPS (Pediatric Medicine), Clinical Fellow Neonatology, 

Muhammad Sohail Arshad, The Children’s Hospital and Institute of Child Health, Multan, Pakistan.

FCPS (Pediatric Cardiology), FCPS (Pediatric Medicine), Professor Pediatric Cardiology, 

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Published

2025-03-10

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Section

Origianl Article