Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial
Abstract Background Since inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. In searching the literature, no previous research addressed the role of Montelukast in neonatal sepsis; hence, thi...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2023-12-01
|
| Series: | Egyptian Pediatric Association Gazette |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s43054-023-00210-w |
| _version_ | 1797398180574265344 |
|---|---|
| author | Nouran El-Shehaby Heba Abdelhameed El-Shahawy Nehad Nasef Shadia El-Sallab Hanan EL-Halaby |
| author_facet | Nouran El-Shehaby Heba Abdelhameed El-Shahawy Nehad Nasef Shadia El-Sallab Hanan EL-Halaby |
| author_sort | Nouran El-Shehaby |
| collection | DOAJ |
| description | Abstract Background Since inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. In searching the literature, no previous research addressed the role of Montelukast in neonatal sepsis; hence, this study aimed to explore the adjuvant role of Montelukast in regulating the inflammatory response associated with neonatal sepsis and its associated effect on the clinical outcomes. Methods An open-label, randomized controlled intervention trial conducted on 40 late preterm newborn infants (gestational age 340/7 to 366/7 weeks) admitted to NICU, with clinical evidence of sepsis. In the Montelukast group (n = 20), infants received oral Montelukast once daily for 10 days (infant's weight < 2 kg received 1.5 mg whereas > 2 kg received 2 mg) with antibiotics plus routine supportive care. In the routine care group (n = 20), infants received antibiotics plus routine supportive care. Primary outcome was the serum level of tumor necrosis factor (TNF) alpha at day 10 of therapy. Secondary clinical and laboratory outcomes were reported along hospital admission. Results Baseline characteristics were non-significantly different between both groups. After 10 days of therapy, TNF alpha level was significantly lower in the Montelukast group (80.73 ± 50.25 versus 119.54 ± 58.46; p = 0.03). There were non-significant differences between both groups regarding duration of NICU admission, antibiotics duration or modalities and duration of respiratory support. C-reactive protein didn’t differ between both groups (p = 0.256). No documented significant adverse effects of Montelukast during the study period. Conclusions In late preterm neonates with sepsis, 10 days of Montelukast therapy as an adjuvant to antibiotics lowered TNF alpha level without any impact on clinical outcomes. Trial registration The study was approved by Mansoura Faculty of Medicine institutional research board (IRB) (MS/17.06.95) and it was registered in clinical trials database (clinicaltrials.gov, ID: NCT04474327 ; registered July 16, 2020). |
| first_indexed | 2024-03-09T01:21:03Z |
| format | Article |
| id | doaj.art-f56aaf8bd3194e6181554c305f195913 |
| institution | Directory Open Access Journal |
| issn | 2090-9942 |
| language | English |
| last_indexed | 2024-03-09T01:21:03Z |
| publishDate | 2023-12-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Egyptian Pediatric Association Gazette |
| spelling | doaj.art-f56aaf8bd3194e6181554c305f1959132023-12-10T12:10:57ZengSpringerOpenEgyptian Pediatric Association Gazette2090-99422023-12-0171111010.1186/s43054-023-00210-wRole of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trialNouran El-Shehaby0Heba Abdelhameed El-Shahawy1Nehad Nasef2Shadia El-Sallab3Hanan EL-Halaby4Neonatal Intensive Care Unit, Mansoura Insurance HospitalDepartment of Clinical Pathology, Faculty of Medicine, Mansoura University Children’s Hospital, Mansoura UniversityNeonatal Intensive Care Unit, Faculty of Medicine, Mansoura University Children Hospital, Mansoura UniversityNeonatal Intensive Care Unit, Faculty of Medicine, Mansoura University Children Hospital, Mansoura UniversityPediatric Intensive Care Unit, Faculty of Medicine, Mansoura University Children Hospital, Mansoura UniversityAbstract Background Since inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. In searching the literature, no previous research addressed the role of Montelukast in neonatal sepsis; hence, this study aimed to explore the adjuvant role of Montelukast in regulating the inflammatory response associated with neonatal sepsis and its associated effect on the clinical outcomes. Methods An open-label, randomized controlled intervention trial conducted on 40 late preterm newborn infants (gestational age 340/7 to 366/7 weeks) admitted to NICU, with clinical evidence of sepsis. In the Montelukast group (n = 20), infants received oral Montelukast once daily for 10 days (infant's weight < 2 kg received 1.5 mg whereas > 2 kg received 2 mg) with antibiotics plus routine supportive care. In the routine care group (n = 20), infants received antibiotics plus routine supportive care. Primary outcome was the serum level of tumor necrosis factor (TNF) alpha at day 10 of therapy. Secondary clinical and laboratory outcomes were reported along hospital admission. Results Baseline characteristics were non-significantly different between both groups. After 10 days of therapy, TNF alpha level was significantly lower in the Montelukast group (80.73 ± 50.25 versus 119.54 ± 58.46; p = 0.03). There were non-significant differences between both groups regarding duration of NICU admission, antibiotics duration or modalities and duration of respiratory support. C-reactive protein didn’t differ between both groups (p = 0.256). No documented significant adverse effects of Montelukast during the study period. Conclusions In late preterm neonates with sepsis, 10 days of Montelukast therapy as an adjuvant to antibiotics lowered TNF alpha level without any impact on clinical outcomes. Trial registration The study was approved by Mansoura Faculty of Medicine institutional research board (IRB) (MS/17.06.95) and it was registered in clinical trials database (clinicaltrials.gov, ID: NCT04474327 ; registered July 16, 2020).https://doi.org/10.1186/s43054-023-00210-wAnti-inflammatoryMontelukast sodiumPremature infantsSepsisTumor necrosis factor alpha |
| spellingShingle | Nouran El-Shehaby Heba Abdelhameed El-Shahawy Nehad Nasef Shadia El-Sallab Hanan EL-Halaby Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial Egyptian Pediatric Association Gazette Anti-inflammatory Montelukast sodium Premature infants Sepsis Tumor necrosis factor alpha |
| title | Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial |
| title_full | Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial |
| title_fullStr | Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial |
| title_full_unstemmed | Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial |
| title_short | Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial |
| title_sort | role of montelukast in modulation of response to sepsis in preterm infants a randomized controlled trial |
| topic | Anti-inflammatory Montelukast sodium Premature infants Sepsis Tumor necrosis factor alpha |
| url | https://doi.org/10.1186/s43054-023-00210-w |
| work_keys_str_mv | AT nouranelshehaby roleofmontelukastinmodulationofresponsetosepsisinpreterminfantsarandomizedcontrolledtrial AT hebaabdelhameedelshahawy roleofmontelukastinmodulationofresponsetosepsisinpreterminfantsarandomizedcontrolledtrial AT nehadnasef roleofmontelukastinmodulationofresponsetosepsisinpreterminfantsarandomizedcontrolledtrial AT shadiaelsallab roleofmontelukastinmodulationofresponsetosepsisinpreterminfantsarandomizedcontrolledtrial AT hananelhalaby roleofmontelukastinmodulationofresponsetosepsisinpreterminfantsarandomizedcontrolledtrial |