Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis

September 25, 2017 updated by: Mohamed Hussein Metwally
Assess the efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a marker of oxidative stress and by comparing other clinical and laboratory parameters of sepsis in both groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized controlled trial. It will be provisionally conducted on 55 neonates admitted to the neonatal intensive care units (NICUs) of Ain Shams University Hospitals, Cairo, Egypt.

Inclusion criteria:

The study will include:Preterm infants (less than 37 weeks gestational age). Evidence of neonatal sepsis.

Exclusion Criteria: Neonate with evidence of any of the following will be excluded:

Infants with hypoxic ischemic encephalopathy. Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Group Classification:

Studied neonates will be completely evaluated and subsequently discriminated, into 2 main groups:Sepsis group: including neonates with proved sepsis. These will be subsequently randomized by permuted block randomization according to sequence of enrollment into:Subgroup A: neonates with odd numbers will receive melatonin.

Subgroup B: neonates with even numbers will not receive the medicine. Non Sepsis group: healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.

Diagnosis of neonatal sepsis will be established based on the presence of: risk factors of sepsis (e.g., prematurity, chorioamnionitis), any clinical evidence suggestive of sepsis, quantitative C-reactive protein (CRP) levels ≥6 mg/dL, Rodwell's hematological scores ≥3, with or without positive blood culture results

  1. Comprehensive history taking including:

    A.Antenatal history: Maternal age, maternal diseases; Maternal diabetic control, maternal fever, infection, prolonged rupture of membranes >=18 hours, malodorous vaginal discharge.

    B.Natal history: Gestational age, sex, and mode of delivery. C.Postnatal history: APGAR score, Respiratory distress and/or cyanosis.

  2. Gestational age will be estimated using the date of the last menstrual period, early antenatal ultrasound if present when available and confirmed by the new Ballard scoring system
  3. Full clinical examination including: chest, cardiac, abdominal and neurological examination.
  4. Clinical signs of infection: lethargy, irritability, prolonged capillary refill, tachycardia, respiratory distress, apnea, convulsions, abdominal distension, feeding intolerance, hyperglycemia, temperature instability and bleeding.
  5. Assessment of the hemodynamic state of the neonates: mean arterial blood pressure (MABP), urinary output, temperature, capillary refill time.

  6. Laboratory investigations Complete blood picture (CBC) with differential leucocytic count. C- reactive protein (CRP) quantitative assay. Blood cultures. MDA assay: blood samples will be collected in plain tubes from peripheral veins or central venous access. Samples will be allowed to clot before centrifugation for 15 minutes and serum will be stored at (-20 degree C) until MDA analysis using MDA competitive ELISA-kit.

    Blood samples will be collected from all included neonates at enrollment and in day one for healthy group.

    As for subgroup A, other samples will be withdrawn at 4 and 72 hours after melatonin administration to assess serum level of malondialdehyde while for subgroup B another sample will be withdrawn after 72 hours

  7. Melatonin Medication:

    Melatonin 10 mg rapid release capsules (puritans pride) will be used. Melatonin will be given at a total dose of 20 mg dissolved in 4 ml of distilled water via enteral route in two doses of 10 mg each(2 ml ), with a 1-hour interval.(Gitto et al., 2000)

  8. Treatment protocol: All neonates will be managed according to the protocol of NICU beside routine neonatal care.

Babies admitted to NICU will be bathed, placed in incubator, attached to monitor.

Cannula will be inserted, IV fluids is started and IV antibiotics. If there is respiratory distress: O2 or ventilation is started, usually feeds are delayed to day 2 or day 3 (or even later) according the severity of condition (clinical decision according to the attending neonatologist).

If no distress and the baby is well: trophic feeds will be started (10ml/kg/day milk), feeds are increased in 10-20ml/kg/day according to baby tolerance, and the condition of the baby (clinical decision according to the attending neonatologist), IV fluids are reduced gradually.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Preterm infants ( less than 37 weeks gestational age). Evidence of neonatal sepsis

Exclusion Criteria:

Infants with hypoxic ischemic encephalopath Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sepsis A Group
neonates diagnosed with Sepsis and will receive melatonin. 10 mg product as a total dose of 20 mg .together with conventional treatment of Neonatal sepsis
Drug: Melatonin 10 mg
Melatonin will be given at a total dose of 20 mg dissolved in 4 ml of distilled water via enteral route in two doses of 10 mg each(2 ml ), with a 1-hour interval. to one group together with conventional treatment
Combination product: Conventional treatment of neonatal sepsis
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
SHAM_COMPARATOR: Sepsis B Group
neonates diagnosed with Sepsis and willnot receive melatonin., they will recieve only the conventional treatment of Neonatal Sepsis
Combination product: Conventional treatment of neonatal sepsis
Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
NO_INTERVENTION: Control
healthy neonates, in whom sepsis will be ruled-out on the basis of absence of any clinical or laboratory evidence suggestive of infection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Melatonin as an antioxidant and free radicals scavenger in Neonatal sepsis
Time Frame: 3 days
efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a marker of oxidative stress
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
melatonin as an adjuvant in management of neonatal sepsis
Time Frame: 3 days
efficacy of melatonin as an adjuvant in the treatment of septic preterms compared to those on conventional treatment and by comparing other clinical and laboratory parameters of sepsis in both groups
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mohamed Hussein Metwally

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pediatrics Dept-ASU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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