CompletedNot Applicable

New Protocol for Febrile Neonate Management

Turkey (Türkiye)328 participantsStarted 2011-01-01

Plain-language summary

The objective of present study was to evaluate clinical and laboratory characteristics of febrile neonate and describe the incidence of SBI in febrile neonates. Secondarly investigators aimed to test usefulness of major protocols and new protocol in evaluating only febrile neonate.

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All neonates who were admitted to the neonatal intensive care unit with a rectal temperature of ≥38°C (documented at the time of medical evaluation) were eligible for the participation in this study. Exclusion Criteria: * The exclusion criteria were gestational age less than 35 weeks, who refused to participate in the study, chromosome abnormality (e.g., trisomy 21, 18), the presence of a chronic disease, congenital malformations (cyanotic heart disease, meningomyelocele), admission to pediatric surgery, started on antibiotics before admission, and incomplete records.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of characteristics of febrile neonate and describe the incidence of SBI in febrile neonates.

Timeframe: 5 years

Usefulness of major protocols and new protocol in evaluating only febrile neonate.

Timeframe: 5 years

Trial details

NCT IDNCT03183531

SponsorSisli Hamidiye Etfal Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-12-31

View on ClinicalTrials.gov More Newborn; Infection trials

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.