Neonatal Late Onset SepsisPhase 3NCT02163174
Pentoxifylline and Late Onset Sepsis in Preterm Infants
A Phase 3 study testing Pentoxifylline (PTX) in people with Neonatal Late Onset Sepsis, run by Abd Elazeez Attala Shabaan at 1 site in Egypt.
Trial summary
Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity. Read more about this study
- Who is it for?
- Ages 5 days to 7 weeks
- Conditions the study is for
- Neonatal Late Onset Sepsis
- What is being tested?
- Pentoxifylline (PTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- May 2011to Jun 2013
- Phase
- Phase 3
- 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 5 days to 7 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis
Who cannot join
- Preterm infants with major congenital malformations
- Preterm infants with chromosomal anomalies
- Preterm infants with inborn-errors of metabolism
- Preterm infants with congenital infection
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Children Hospital
Al Mansurah, Eldakahlia, 35516
About this study
Official title: Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
- Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
- The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
Read the detailed description
- Role of pentoxifylline, a phosphodiesterase inhibitor, in reducing mortality associated with neonatal sepsis is not well studied.
- Hypothesis: we hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
- Purpose of the study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
- Design: A prospective, randomized, double-blind clinical trial.
- Setting: Neonatal Intensive Care Unit, Mansoura University Children's Hospital.
- Patients: 120 preterm infants with suspected or confirmed LOS.
- Intervention: Enrolled infants were randomly assigned to receive intravenous Pentoxifylline (5 mg/kg/hr for 6 hours on 6 successive days) or placebo in addition to antibiotics.
- Primary outcome: Death before hospital discharge.
- Secondary outcomes: Length of hospital stay, duration of respiratory support, duration of antibiotics use, chronic lung disease, necrotizing enterocolitis, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, Serum levels of Tumor necrosis factor, C-Reactive protein levels, and adverse effects of Pentoxifylline.
- Conditions
- Neonatal Late Onset Sepsis
- Being tested
- Pentoxifylline (PTX), Placebo
- Keywords
- neonatal, pentoxifylline, randomized controlled trial
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline (PTX)Drug
Also called Trental (brand name)
Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics
PlaceboDrug
Patients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Pentoxyfilline arm | Active comparator | Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics. Receives: Drug: Pentoxifylline (PTX) |
| Placebo arm | Placebo comparator | Intravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality
Mortality before discharge from neonatal intensive care unit
Measured: Expected 10 weeks postnatal age
Secondary outcomes (10)
Length of hospital stay
Duration of hospital admission (days)
Measured: Expected average of 8 weeks post natal age
Duration of respiratory support
Duration of respiratory support including oxygen, Continuous Positive Airway Pressure, mechanical ventilation(days)
Measured: Expected 4 to 6 weeks postnatal age
Duration of antibiotics use
Duration of treatment of sepsis including meningitis
Measured: Expected 3 to 5 weeks postnatal age
Chronic lung disease
Need for oxygen by 36 weeks corrected gestational age
Measured: By 36 weeks corrected gestational age
Necrotising enterocolitis
Bell clinical and radiological criteria
Measured: Expected 6 weeks
Intraventricular haemorrhage
By cranial ultrasound grading
Measured: Expected 2 weeks
Periventricular leukomalacia
By cranial ultrasound
Measured: Expected 8 weeks
Retinopathy of prematurity
Ophthalmologist using Ret-Cam
Measured: Expected 8 weeks
Serum levels of Tumor necrosis factor-α, C-Reactive protein
Measured: 6 days after intervention
Adverse effects of Pentoxifylline
Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis.
Measured: Up to 10 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Late Onset 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abd Elazeez Attala Shabaan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abd Elazeez Attala Shabaan, Mansoura University
- Investigators
- Abd Elazeez AT Shabaan, PhD, Principal investigator, Mansoura University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163174
- Sponsor's protocol ID
- 12345
- Other IDs
- R88
- Status last verified
- Jun 2014
- First submitted
- 6 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shabaan AE, Nasef N, Shouman B, Nour I, Mesbah A, Abdel-Hady H. Pentoxifylline therapy for late-onset sepsis in preterm infants: a randomized controlled trial. Pediatr Infect Dis J. 2015 Jun;34(6):e143-8. doi: 10.1097/INF.0000000000000698.
PubMed 25970116
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02163174
- Acronym / sponsor ID
- 12345
- Conditions
- Neonatal Late Onset Sepsis
- Keywords
- neonatal, pentoxifylline, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Abd Elazeez Attala ShabaanUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Jun 2014 (estimated)
- 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.
- Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
- The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
Detailed description
- Role of pentoxifylline, a phosphodiesterase inhibitor, in reducing mortality associated with neonatal sepsis is not well studied.
- Hypothesis: we hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
- Purpose of the study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
- Design: A prospective, randomized, double-blind clinical trial.
- Setting: Neonatal Intensive Care Unit, Mansoura University Children's Hospital.
- Patients: 120 preterm infants with suspected or confirmed LOS.
- Intervention: Enrolled infants were randomly assigned to receive intravenous Pentoxifylline (5 mg/kg/hr for 6 hours on 6 successive days) or placebo in addition to antibiotics.
- Primary outcome: Death before hospital discharge.
- Secondary outcomes: Length of hospital stay, duration of respiratory support, duration of antibiotics use, chronic lung disease, necrotizing enterocolitis, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, Serum levels of Tumor necrosis factor, C-Reactive protein levels, and adverse effects of Pentoxifylline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxyfilline arm | Active comparator | Drug: Pentoxifylline (PTX)Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics. |
| Placebo arm | Placebo comparator | Drug: PlaceboIntravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics. |
Who may qualify
- Ages
- 5 days to 7 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis
Key exclusion criteria (4 listed)
- Preterm infants with major congenital malformations
- Preterm infants with chromosomal anomalies
- Preterm infants with inborn-errors of metabolism
- Preterm infants with congenital infection
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 |
|---|---|---|
| Pentoxifylline (PTX)Also: Trental (brand name)Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics | Drug | Pentoxyfilline arm |
| PlaceboPatients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics. | Drug | Placebo arm |
Primary outcome
Neonatal mortality
Time frame: Expected 10 weeks postnatal age
Mortality before discharge from neonatal intensive care unit
10 secondary outcomes
Length of hospital stay
Time frame: Expected average of 8 weeks post natal age
Duration of respiratory support
Time frame: Expected 4 to 6 weeks postnatal age
Duration of antibiotics use
Time frame: Expected 3 to 5 weeks postnatal age
Chronic lung disease
Time frame: By 36 weeks corrected gestational age
Necrotising enterocolitis
Time frame: Expected 6 weeks
Intraventricular haemorrhage
Time frame: Expected 2 weeks
Periventricular leukomalacia
Time frame: Expected 8 weeks
Retinopathy of prematurity
Time frame: Expected 8 weeks
Serum levels of Tumor necrosis factor-α, C-Reactive protein
Time frame: 6 days after intervention
Adverse effects of Pentoxifylline
Time frame: Up to 10 days after intervention
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 16 Jun 2014.
- Derived from this study: PubMed 25970116Shabaan AE, Nasef N, Shouman B, Nour I, Mesbah A, Abdel-Hady H. Pentoxifylline therapy for late-onset sepsis in preterm infants: a randomized controlled trial. Pediatr Infect Dis J. 2015 Jun;34(6):e143-8. doi: 10.1097/INF.0000000000000698.
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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.
Abd Elazeez AT Shabaan, PhD principal investigator
Mansoura University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pentoxifylline (PTX) in people with Neonatal Late Onset Sepsis, run by Abd Elazeez Attala Shabaan 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 4 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 16 Jun 2014. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Neonatal mortality (time frame: Expected 10 weeks postnatal age). 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 NCT02163174, which also lists 1 linked publication.
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 16 Jun 2014.