Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium sulfate, Sildenafil Citrate, Isotonic saline.
- Who it may be relevant to
- Registry conditions: Persistent Pulmonary Hypertension of Newborn. Basic parameters: 6 Hours — 72 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn
Overview
The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.
Detailed description
Persistent pulmonary hypertension of newborn (PPHN) is a serious condition that results from failure of the normal postnatal circulatory transition and is associated with significant mortality and morbidity. Advanced medical treatment, such as inhaled nitric oxide (iNO), high-frequency ventilation (HFV), and extracorporeal membrane oxygenation (ECMO) are commonly not available in developing countries. Intravenous magnesium sulfate has been shown to alleviate pulmonary hypertension but is associated with systemic hypotension and is less effective compared with iNO and sildenafil. Nebulized magnesium sulfate has been reported to be more effective and safer compared with intravenous magnesium sulfate in treating neonates with PPHN on mechanical ventilation. Combined nebulized magnesium and sildenafil has been studied in a small trial on spontaneously breathing neonates with PPHN but not on those connected to mechanical ventilation.
The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe PPHN on mechanical ventilation. We hypothesize that neonates with severe PPHN connected to mechanical ventilation could benefit from taking continuous nebulization of magnesium sulfate combined besides sildenafil.
Interventions
- Drug Magnesium sulfate
Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes - Drug Sildenafil Citrate
Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours. - Other Isotonic saline
Nebulized isotonic saline (4 ml) every 15 minutes
Primary outcome measures
- Change in Oxygenation index (OI) [Time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration]
Secondary outcome measures (4)
- Change in Mean arterial blood pressure (MABP) [Time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration.]
- Change in Vasoactive Inotropic Score (VIS) [Time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration.]
- Change in Pulmonary artery systolic pressure (PASP) [Time frame: From baseline to 24 hours after study drug administration]
- Change in Serum magnesium level [Time frame: From baseline to 24 hours after study drug administration]
Eligibility criteria
Inclusion criteria
- Gestational age ≥ 36 weeks
- Birth weight between 2.5 and 4 kg.
- Post-natal age between 6 and 72 hours.
- PPHN confirmed by echocardiography
- Oxygenation index (OI) > 30 on two occasions at least 15 minutes apart
- Connected to Mechanical Ventilation
Exclusion criteria
- Failure to obtain informed consent
- Newborns to mothers who received magnesium sulfate within 48 hours before labor.
- Congenital heart diseases, other than patent ductus arteriosus and foramen ovale.
- Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
- Prior need for cardiopulmonary resuscitation.
- Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
- Impaired kidney function.
- Prior administration of pulmonary vasodilators.
- Gastrointestinal intolerance or bleeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Neonatal Intensive Care Unit, Sohag University Hospital — Sohag
Publications
- Abdelkreem E, Mahmoud SM, Aboelez MO, Abd El Aal M. Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of Newborn: A Pilot Randomized Controlled Trial. Indian J Pediatr. 2021 Aug;88(8):771-777. doi: 10.1007/s12098-020-03643-y. Epub 2021 Jan 8. PMID 33415555
- Mandell E, Kinsella JP, Abman SH. Persistent pulmonary hypertension of the newborn. Pediatr Pulmonol. 2021 Mar;56(3):661-669. doi: 10.1002/ppul.25073. PMID 32930508
- El-Khuffash A, McNamara PJ, Breatnach C, Bussmann N, Smith A, Feeney O, Tully E, Griffin J, de Boode WP, Cleary B, Franklin O, Dempsey E. The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1): study protocol and review of literature. Matern Health Neonatol Perinatol. 2018 Dec 3;4:24. doi: 10.1186/s40748-018-0093- PMID 30524749
- Lai MY, Chu SM, Lakshminrusimha S, Lin HC. Beyond the inhaled nitric oxide in persistent pulmonary hypertension of the newborn. Pediatr Neonatol. 2018 Feb;59(1):15-23. doi: 10.1016/j.pedneo.2016.09.011. Epub 2017 Aug 10. PMID 28923474
- Nakwan N. The Practical Challenges of Diagnosis and Treatment Options in Persistent Pulmonary Hypertension of the Newborn: A Developing Country's Perspective. Am J Perinatol. 2018 Dec;35(14):1366-1375. doi: 10.1055/s-0038-1660462. Epub 2018 Jun 19. PMID 29920641
- He Z, Zhu S, Zhou K, Jin Y, He L, Xu W, Lao C, Liu G, Han S. Sildenafil for pulmonary hypertension in neonates: An updated systematic review and meta-analysis. Pediatr Pulmonol. 2021 Aug;56(8):2399-2412. doi: 10.1002/ppul.25444. Epub 2021 May 13. PMID 33983650
- Ho JJ, Rasa G. Magnesium sulfate for persistent pulmonary hypertension of the newborn. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD005588. doi: 10.1002/14651858.CD005588.pub2. PMID 17636807
Identifiers
NCT: NCT04898114 · Neb-Mag-2