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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Postoperative Infection Rates

Intervention / Treatment
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* Drug: Local Rifampisin and İnrtravenous cefotaxime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns who have open NTDs Exclusion Criteria: Healthy newborns

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rifampisin group<br>Researchers will administer topical Rifampicin and intravenous cefotaxime For Rifampicin; 10 mg/kg/day, 24 h infusion on defect area during 3 days For cefotaxime; 50 mg/kg/day, twice a day, intravenous during 5 days. | Drug: Local Rifampisin and İnrtravenous cefotaxime<br> <br> * Other names: Only intravenous cefotaxim;|
| Control group<br>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<br> <br> * Other names: Only intravenous cefotaxim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infections | 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. | within 30 days | 
| The diagnosis of ventriculoperitoneal (VP) shunt infection | 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: the identification of organisms on a culture or Gram stain from cerebrospinal fluid (CSF), a wound swab or pseudocyst fluid; wound breakdown with visible shunt hardware; the presence of an abdominal pseudocyst (even in the absence of positive cultures); or positive blood cultures in a baby with a VP shunt. | within one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | Researchers will evaluate as follows: 1)Length of hospitalization, 1)The cost of hospitalization. | within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical rifampicin, neural tube defects, infection, newborn