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Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants

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ClinicalTrials.gov Identifier: NCT03198819
Recruitment Status : Unknown
Verified June 2017 by nihat demir, Yuzuncu Yıl University.
Recruitment status was:  Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
nihat demir, Yuzuncu Yıl University

Brief Summary:
The correct timing and technique of neural tube defect (NTD) repairs significantly decreases the morbidity and mortality of NTD cases. However, infections related to the surgery are still common. We investigated the effects of topical rifampicin (RIF) combined with routine prophylaxis in newborns with open NTD.

Condition or disease Intervention/treatment
Postoperative Infection Rates Drug: Local Rifampisin and İnrtravenous cefotaxime

Detailed Description:

The study will be conducted in the Yuzuncu Yil University neonatal intensive care unit, Van, Turkey. The data of 60 neonates diagnosed with open NTD, who will be underwent surgical intervention between August 2016 and December 2017, will be prospectively evaluated. These cases will be randomised.These neonates are going to divide into two groups: the experimental group and the control group. The experimental group will be consisted of 30 newborns diagnosed with open NTDs, administered topical RIF (10 mg/kg/day, 24 h infusion) and cefotaxime (50 mg/kg/day, two doses, iv), and the control group will be consisted of 30 newborns diagnosed with open NTDs, administered cefotaxime (50 mg/kg/day, two doses).

In this study, researchers will be investigated whether prophylactic topical RIF applied on a pre-operative mesh in newborns with open NTD reduce the rate of SSIs and meningitis/ VP shunt infections after surgery. For deep incisional primary SSIs will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC) (1). The diagnosis of VP shunt infections will be made after extensive clinical and laboratory evaluations. the diagnosis of to make shunt infections, criteria of the Hydrocephalus Clinical Research Network (HCRN) will be taken into consideration (2).

Topical RIF Application Procedure The NTD site will be covered with a sterile gauze dressing in the first hours of life after birth in all babies with open NTDs. Then, 10 mg/kg/day RIF will be added to 24 ml of saline (0,9% NaCl), and this will be applied to the mesh as an infusion at a 1cc/h speed . Every day, the same dose of RIF will be delivered to the mesh,changed daily, as a 24-hour infusion until the patient could be operated. After the patient is operated, the RIF infusion delivered to the mesh will be stopped. The cefotaxime treatment will be continued until 72 hours post-op (3).


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants
Study Start Date : August 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Rifampisin group

Researchers will administer topical Rifampicin and intravenous cefotaxime

  1. For Rifampicin; 10 mg/kg/day, 24 h infusion on defect area during 3 days
  2. For cefotaxime; 50 mg/kg/day, twice a day, intravenous during 5 days.
Drug: Local Rifampisin and İnrtravenous cefotaxime
Other Name: Only intravenous cefotaxim

Control group

Researchers will only administer intravenous cefotaxime

1) Doses; 50 mg/kg/day, twice a day, intravenous during 5 days.

Drug: Local Rifampisin and İnrtravenous cefotaxime
Other Name: Only intravenous cefotaxim




Primary Outcome Measures :
  1. Surgical site infections [ Time Frame: within 30 days ]
    Deep incisional primary surgical site infections (SSIs) will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC). Accordingly, a diagnosis of infection will be established when fasciae, muscles or deep soft tissues associated with a surgical incision are affected within the first 30 postoperative days or when a foreign body (implant, etc.) leaves at the operation site will be observed within one year after the operation.

  2. The diagnosis of ventriculoperitoneal (VP) shunt infection [ Time Frame: within one month ]

    The diagnosis of VP shunt infections will be made after extensive clinical and laboratory evaluations. The diagnosis of to make shunt infections, criteria of the Hydrocephalus Clinical Research Network (HCRN) will be taken into consideration.

    Shunt infection will be defined as follows:

    1. the identification of organisms on a culture or Gram stain from cerebrospinal fluid (CSF), a wound swab or pseudocyst fluid;
    2. wound breakdown with visible shunt hardware;
    3. the presence of an abdominal pseudocyst (even in the absence of positive cultures); or
    4. positive blood cultures in a baby with a VP shunt.


Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: within 6 months ]

    Researchers will evaluate as follows:

    1)Length of hospitalization,

    1)The cost of hospitalization.




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in the Yuzuncu Yil University neonatal intensive care unit, Van, Turkey. The data of 60 neonates diagnosed with open NTD, who will be underwent surgical intervention between August 2016 and December 2017, will be prospectively evaluated. These cases will be randomised.These neonates are going to divide into two groups: the experimental group and the control group. The experimental group will be consisted of 30 newborns diagnosed with open NTDs, administered topical RIF (10 mg/kg/day, 24 h infusion) and cefotaxime (50 mg/kg/day, two doses, iv), and the control group will be consisted of 30 newborns diagnosed with open NTDs, administered cefotaxime (50 mg/kg/day, two doses).
Criteria

Inclusion Criteria:

  • Newborns who have open NTDs

Exclusion Criteria:

  • Healthy newborns

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198819


Contacts
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Contact: ibrahim deger, MD +905052710158 drdeger@gmail.com
Contact: nihat demir 5326039081 demirnihat27@hotmail.com

Locations
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Turkey
Yuzuncu yil medical school Recruiting
Van, Outside of the US, Turkey, 65250
Contact: nihat demir    5326039081    demirnihat27@hotmail.com   
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Study Director: nihat demir yüzüncüyıl üniversitesi

Publications of Results:
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Responsible Party: nihat demir, M.D, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03198819     History of Changes
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by nihat demir, Yuzuncu Yıl University:
Topical rifampicin, neural tube defects, infection, newborn
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Rifampin
Cefotaxime
Cefoxitin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers