Neonatal SepsisPhase 1NCT04474327
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
A Phase 1 study testing Montelukast Sodium in people with Neonatal Sepsis, run by Mansoura University Children Hospital at 1 site in Egypt.
Trial summary
The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Montelukast Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jul 2020to 10 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Infants with gestational age from 34 weeks to less than 37 weeks (late preterm) and weighted more than 1.5 Kg with clinical evidence of neonatal sepsis (Wynn 2016).
Who cannot join
- 1. Infants presented initially with septic shock, multi-organ dysfunction syndrome (MODS), disseminated intravascular coagulopathy.
- 2. Infants with major congenital malformations 3. Infants with chromosomal aberrations 4. Postoperative patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Childran Hospital
Al Mansurah, Dakahlia Governorate, 35116
About this study
The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.
Read the detailed description
Since inflammatory mediators play a crucial role in the pathophysiology of sepsis so anti-inflammatory treatment, Montelukast, could be a beneficial therapy. The investigators will conduct this pilot, open-labeled, randomized controlled intervention trial on 40 newborns admitted to NICU. The study will include late preterm infants with gestational age (34 weeks to less than 37 weeks) with clinical evidence of sepsis. The study included an intervention group (n=20) that will receive oral Montelukast for 10 days with antibiotics in addition to the conventional antibiotic therapy regimen according to NICU policy while the control group (n=20) will receive antibiotics in addition to the conventional antibiotic therapy regimen according to NICU policy. After obtaining a fully informed written consent from the neonate's parents or guardians, patients will be recruited and group allocated in the study by random pick up of closed opaque sealed envelopes. Patients will be observed clinically and by laboratory investigations along the duration of hospital admission through a structured collection sheet. Demographic data, cause of admission, clinical data (vital signs, activity, feeding intolerance, respiratory symptoms, duration of oxygen support, use of inotropes) will be recorded. Blood sampling will be performed twice in both groups, on admission, and 10 days after treatment. The following investigations will be carried out: complete blood picture, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF alpha), blood culture, Serum creatinine, Liver enzymes, and INR. A lumbar puncture will be performed when the treating physicians suspect meningitis. Patients in both groups will be observed along the duration of hospital admission to detect the outcome.
Patients in the intervention group, receiving Montelukast sodium (Singulair), will be given at a dose according to body weight (1.5 kg to 2 kg, will be given 1.5 mg; greater than 2 kg, will be given 2 mg). This dose was previously prescribed and given to preterm neonates suffered from bronchopulmonary dysplasia by Kim et al. (2015). Four mg of the drug will be dissolved in four ml milk and 1.5 - 2 ml milk only will be given once daily at 9 pm via an orogastric tube or by oral administration for 10 days. Along the period of NICU admission, patients receiving Montelukast will be closely observed for the development of any of its side effects that including "diarrhea, colic, vomiting, fever or cough" (Adelsberg et al., 2005).
- Conditions
- Neonatal Sepsis
- Being tested
- Montelukast Sodium
- Keywords
- Sepsis, Montelukast, TNF alpha, premature infant
- Medical subject headings
- Neonatal Sepsis, Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast SodiumDrug
Also called Singulair
Montelukast sodium (Singulair) will be given at a dose according to body weight. Four mg of the drug will be dissolved in four ml milk and the dose will be given once daily at 9 pm for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive Montelukast Sodium for 10 days in addition to the conventional antibiotic therapy regimen and other supportive measures according to the policy of neonatal units and patients' needs. Montelukast sodium will be given at a dose according to body weight (1.5 kg to 2 kg, will be given 1.5 mg; greater than 2 kg, 2 mg will be given) this dose was calculated according to ( Kim et al. (2015). Four mg of the drug will be dissolved in four ml milk and 1.5 - 2 ml milk only will be given once daily at 9 pm via an orogastric tube or by oral administration for 10 days and patients of this group will be closely observed for development of Montelukast side effects as "diarrhea, colic, vomiting, fever and cough" (Adelsberg et al. 2005). Receives: Drug: Montelukast Sodium |
| Control group | No intervention | The control group will receive antibiotics and other supportive measures according to the policy of neonatal units and patients' needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum tumor necrosis factor (TNF) Alpha level
Change in serum level of TNF alpha is assessed by the difference between the admission level and its level at 10 days after receiving the therapy.
Measured: Measured twice: on admission and 10 days after receiving therapy
Secondary outcomes (5)
The duration of NICU admission
the total duration of NICU admission
Measured: Counting the total duration of NICU admission
Change in serum C-reactive protein (CRP) level
Serum C-reactive protein (CRP) level will be measured on admission and compare its level with the level at 10 days after receiving therapy. It will be measured in both groups
Measured: Measured twice: on admission and 10 days after receiving therapy
Patients improvement, deterioration (Clinically and laboratory) or death
Patients are considered 1.improved when manifested clinically by no respiratory distress, normal temperature, no oxygen support, no inotropes, alert, not lethargic, tolerate feeding, increasing in body weight and laboratory by normal CBC , normal CRP, Culture negative. 2. Partially improved if patient still on intravenous fluid therapy, still on oxygen support, still on inotropes, CRP decreasing but still positive, and CBC still abnormal. 3. Deteriorated if developed complication as coagulopathy, septic shock or MODS.
Measured: determined at 10 days after receiving therapy
use of positive pressure ventilation and its duration
use of positive pressure ventilation (receiving mechanical ventilation or CPAP) and the duration
Measured: determined at 10 days after receiving therapy
Duration of use of inotropes
duration of inotropes (dopamine, epinephrine, norepinephrine)
Measured: determined at 10 days after receiving therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start24 Jul 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan El-Halaby, Mansoura University Children Hospital
- Investigators
- Hanan A El-Halaby, Principal investigator, Mansoura University Children Hospital, Gomhuria street, 35116 Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474327
- Sponsor's protocol ID
- Montelukast in neonatal sepsis
- Status last verified
- Feb 2021
- First submitted
- 13 Jul 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.
PubMed 15969897Kim SB, Lee JH, Lee J, Shin SH, Eun HS, Lee SM, Sohn JA, Kim HS, Choi BM, Park MS, Park KI, Namgung R, Park MS. The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia. Korean J Pediatr. 2015 Sep;58(9):347-53. doi: 10.3345/kjp.2015.58.9.347. Epub 2015 Sep 21.
PubMed 26512261
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
- ClinicalTrials.gov ID
- NCT04474327
- Acronym / sponsor ID
- Montelukast in neonatal sepsis
- Conditions
- Neonatal Sepsis
- Keywords
- Sepsis, Montelukast, TNF alpha, premature infant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.
Detailed description
Since inflammatory mediators play a crucial role in the pathophysiology of sepsis so anti-inflammatory treatment, Montelukast, could be a beneficial therapy. The investigators will conduct this pilot, open-labeled, randomized controlled intervention trial on 40 newborns admitted to NICU. The study will include late preterm infants with gestational age (34 weeks to less than 37 weeks) with clinical evidence of sepsis. The study included an intervention group (n=20) that will receive oral Montelukast for 10 days with antibiotics in addition to the conventional antibiotic therapy regimen according to NICU policy while the control group (n=20) will receive antibiotics in addition to the conventional antibiotic therapy regimen according to NICU policy. After obtaining a fully informed written consent from the neonate's parents or guardians, patients will be recruited and group allocated in the study by random pick up of closed opaque sealed envelopes. Patients will be observed clinically and by laboratory investigations along the duration of hospital admission through a structured collection sheet. Demographic data, cause of admission, clinical data (vital signs, activity, feeding intolerance, respiratory symptoms, duration of oxygen support, use of inotropes) will be recorded. Blood sampling will be performed twice in both groups, on admission, and 10 days after treatment. The following investigations will be carried out: complete blood picture, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF alpha), blood culture, Serum creatinine, Liver enzymes, and INR. A lumbar puncture will be performed when the treating physicians suspect meningitis. Patients in both groups will be observed along the duration of hospital admission to detect the outcome.
Patients in the intervention group, receiving Montelukast sodium (Singulair), will be given at a dose according to body weight (1.5 kg to 2 kg, will be given 1.5 mg; greater than 2 kg, will be given 2 mg). This dose was previously prescribed and given to preterm neonates suffered from bronchopulmonary dysplasia by Kim et al. (2015). Four mg of the drug will be dissolved in four ml milk and 1.5 - 2 ml milk only will be given once daily at 9 pm via an orogastric tube or by oral administration for 10 days. Along the period of NICU admission, patients receiving Montelukast will be closely observed for the development of any of its side effects that including "diarrhea, colic, vomiting, fever or cough" (Adelsberg et al., 2005).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Montelukast SodiumThe intervention group will receive Montelukast Sodium for 10 days in addition to the conventional antibiotic therapy regimen and other supportive measures according to the policy of neonatal units and patients' needs. Montelukast sodium will be given at a dose according to body weight (1.5 kg to 2 kg, will be given 1.5 mg; greater than 2 kg, 2 mg will be given) this dose was calculated according to ( Kim et al. (2015). Four mg of the drug will be dissolved in four ml milk and 1.5 - 2 ml milk only will be given once daily at 9 pm via an orogastric tube or by oral administration for 10 days and patients of this group will be closely observed for development of Montelukast side effects as "diarrhea, colic, vomiting, fever and cough" (Adelsberg et al. 2005). |
| Control group | No intervention | –The control group will receive antibiotics and other supportive measures according to the policy of neonatal units and patients' needs. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Infants with gestational age from 34 weeks to less than 37 weeks (late preterm) and weighted more than 1.5 Kg with clinical evidence of neonatal sepsis (Wynn 2016).
Key exclusion criteria (2 listed)
- 1. Infants presented initially with septic shock, multi-organ dysfunction syndrome (MODS), disseminated intravascular coagulopathy.
- 2. Infants with major congenital malformations 3. Infants with chromosomal aberrations 4. Postoperative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast SodiumAlso: SingulairMontelukast sodium (Singulair) will be given at a dose according to body weight. Four mg of the drug will be dissolved in four ml milk and the dose will be given once daily at 9 pm for 10 days. | Drug | Intervention group |
Primary outcome
Change in serum tumor necrosis factor (TNF) Alpha level
Time frame: Measured twice: on admission and 10 days after receiving therapy
Change in serum level of TNF alpha is assessed by the difference between the admission level and its level at 10 days after receiving the therapy.
5 secondary outcomes
The duration of NICU admission
Time frame: Counting the total duration of NICU admission
Change in serum C-reactive protein (CRP) level
Time frame: Measured twice: on admission and 10 days after receiving therapy
Patients improvement, deterioration (Clinically and laboratory) or death
Time frame: determined at 10 days after receiving therapy
use of positive pressure ventilation and its duration
Time frame: determined at 10 days after receiving therapy
Duration of use of inotropes
Time frame: determined at 10 days after receiving therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 15969897van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.
- Results publication: PubMed 26512261Kim SB, Lee JH, Lee J, Shin SH, Eun HS, Lee SM, Sohn JA, Kim HS, Choi BM, Park MS, Park KI, Namgung R, Park MS. The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia. Korean J Pediatr. 2015 Sep;58(9):347-53. doi: 10.3345/kjp.2015.58.9.347. Epub 2015 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan A El-Halaby principal investigator
Mansoura University Children Hospital, Gomhuria street, 35116 Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Montelukast Sodium in people with Neonatal Sepsis, run by Mansoura University Children Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum tumor necrosis factor (TNF) Alpha level (time frame: Measured twice: on admission and 10 days after receiving therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.