An interventional study of Trimethoprim and Simple Syrup in Hydronephrosis and Urinary Tract Infection, sponsored by McMaster University. Active, not recruiting at 2 sites in Canada. Open to participants aged 1 Month to 7 Months. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
This study focuses on the relationship between prophylaxis antibiotics and frequency of urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection of hydronephrosis has become even more common. As a result, thousands of infants with hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists, pediatric urologists, and family physicians. The investigators need to determine if antibiotic prophylaxis is effective in reducing the number of urinary tract infections in this population.
This study focuses on the relationship between prophylaxis antibiotics and frequency of urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection of hydronephrosis has become even more common. As a result, thousands of infants with hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists, pediatric urologists, and family physicians. The investigators need to determine if antibiotic prophylaxis is effective in reducing the number of urinary tract infections in this population.To determine whether CAP reduces the rate of UTI in infants with prenatal HN within the first 18 months of life.
This is superiority, parallel, blinded, randomized, placebo-controlled trial in infants with prenatal HN testing the effect of CAP on febrile UTI rates over the first 18 months of life
For clinical and safety purposes, data will be collected on symptoms and signs of febrile laboratory confirmed UTI (urinalysis, urine culture), compliance to treatment, adverse effects, and resistance to prophylactic antibiotics in case of positive urine cultures. As part of standard medical care, the patient and family are scheduled for renal-bladder ultrasounds and outpatient pediatric urology clinic visits at the local recruitment sites (i.e. McMaster Children's Hospital, The Hospital for Sick Children or, Children's Hospital of Eastern Ontario) during months as mentioned above at baseline, 3, 6, 9 and 12 months . During these clinic appointments, the research coordinator will follow up with patient and family regarding their progress in the study. The Research Coordinator will ask about any side effects from trial medication (nausea, vomiting, gastroenteritis, anaphylactic reactions) and ensure their questions or concerns are addressed. Data from patient's ultrasound assessment and renal scans will also be collected.
In addition to clinic follow ups, patients and their families will be contacted monthly (excluding the months patient is scheduled for clinical follow up) by the Research Coordinator to further monitor patient's study progress. Families will be instructed to call the Research Coordinator at the first sign of febrile UTI (fever, loss of appetite, abdominal pain) and advised to seek medical assistance (bring their child to the Emergency Department at the local study institution). The baby will then have a dipstick taken to test for positive nitrites and leukocytes. If positive, patients are to have a urine sample via catheter specimen taken and if positive, be taken off study medication and be treated for febrile UTI according to standard medical practice. In this case the family and healthcare providers will not be unblinded to the participant's treatment allocation as this information is not required in order to treat the infant. In the event that parents are unable to bring their child to the local study institution, it is advised they obtain a dipstick and a catheter specimen from their local walk-in-clinic, Urgent Care Centre or family physician's office. If a catheter specimen is not available at these locations, a sterile bag may be used to determine outcome of urine sample. To ensure there is consistency between outside facilities, parents are given detailed instructions to obtain a dipstick and provide a photocopy of the results to the Research Coordinator for our records and potential adjudication.
Letters will be faxed to the doctor that treated the child for the suspected UTI in order to obtain the associated reports.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 23 interventional studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prophylactic Antibiotics
Drug: Trimethoprim
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
Other: Simple Syrup
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
To determine whether antibiotics (ATB) prophylaxis prevents urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN).
Determine the rate and frequence of UTI infection
Time frame: The outcome measures will be assessed at 12 months
The record gives a start of Jul 2010, a primary completion of Sep 2024 and a completion of Sep 2024. It does not say whether these dates are actual or estimated.
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This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trimethoprim