Analysis on the Health of Newborns in Three Hospitals, 2008-2024 (NCT06758622) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Analysis on the Health of Newborns in Three Hospitals, 2008-2024
Ecuador40,000 participantsStarted 2024-11-12
Plain-language summary
The objective of this observational study is to analyze the factors associated with neonatal morbidity and mortality in three hospitals in Quito, Ecuador, from January 2022 to December 2023. The primary question to be addressed is:
What perinatal factors are associated with neonatal morbidity and mortality in neonates admitted to HGOIA, HGDC, and HGONA hospitals?
The participants will be neonates whose complete medical records are registered in the Perinatal Information System (SIP) and the Maternal-Perinatal Clinical Record (HCMP) databases during the study period. Data will be retrospectively collected from the mentioned databases, evaluating variables such as birth weight, gestational age, congenital anomalies, neonatal complications, and maternal factors such as age and medical conditions.
The analysis will include prevalence calculations, variable associations through logistic regression, and the development of neonatal growth curves. Statistical software such as R will be used for data analysis, and the results will be compared to national and international standards.
Who can participate
Age range
0 Days – 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:
Neonates registered in the Perinatal Information System or the Maternal-Perinatal Clinical Record during the study period (January 2022 to December 2023).
Neonates born in the participating hospitals: Hospital Gineco Obstétrico Isidro Ayora, Hospital General Docente de Calderón, and Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi.
Perinatal medical records with complete data, including information on birth weight, gestational age, neonatal complications, and maternal conditions.
Exclusion Criteria:
Neonates with incomplete or inconsistent clinical records in the Perinatal Information System or the Maternal-Perinatal Clinical Record.
Perinatal medical records missing key information, such as discharge diagnoses, gestational age, or birth weight.
Neonates born outside the participating institutions during the study period.
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.