An observational study in Preterm Birth, Low Birth Weight and Intrauterine Growth Restriction (IUGR), sponsored by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA. Completed at 1 site in Ecuador. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA · Observational
This study focuses on understanding the conditions that affect newborn health and survival from pregnancy to the first weeks of life at the Isidro Ayora Hospital. The investigators will review data from 2008 to 2022 to identify key factors that may contribute to complications, help improve medical care, and reduce risks for newborns. By doing so, we aim to provide better support to families, healthcare providers, and ensure safer births.
This research investigates the impact of various perinatal conditions-such as maternal health, prenatal complications, delivery methods, and neonatal management-on morbidity and mortality rates in newborns treated at the Isidro Ayora Obstetric-Gynecologic Hospital. Using a retrospective cohort design, the study analyzes data from 2008 to 2022 to identify patterns and correlations between perinatal factors and neonatal outcomes, aiming to inform evidence-based clinical practices and enhance neonatal care protocols.
Key aspects include evaluating the influence of gestational age, birth weight, maternal comorbidities (e.g., hypertension, diabetes), and obstetric complications on the health of neonates. Outcomes of interest include NICU admissions, length of hospital stay, and incidence of conditions such as respiratory distress syndrome, sepsis, and neonatal mortality. Findings will contribute to improving resource allocation, optimizing care strategies, and potentially guiding policy decisions to reduce adverse neonatal outcomes.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 26,000 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →HOSPITAL GINECO OBSTETRICO ISIDRO AYORA is the lead sponsor of 2 studies on the registry; none are open to participants now.
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The study population includes all live-born neonates delivered at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022. The cohort encompasses neonates born to mothers of diverse socioeconomic backgrounds, varying maternal health conditions, and different obstetric risk profiles. The study focuses on evaluating neonatal outcomes based on gestational age, birth weight, and the presence of perinatal complications, such as maternal hypertension, diabetes, or preterm labor. This population represents a high-risk group typical of a tertiary care referral center, allowing for a comprehensive analysis of factors influencing neonatal morbidity and mortality.
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Exclusion Criteria:
The "Infant, Premature" group includes neonates born before 37 weeks of gestation at the Isidro Ayora Obstetric-Gynecologic Hospital. This cohort is particularly vulnerable to a range of complications, including respiratory distress syndrome, intraventricular hemorrhage, and infections, which are major contributors to neonatal morbidity and mortality.
Behavioral: Infant, Premature
This cohort includes all live-born neonates delivered at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022. The study focuses on evaluating the influence of various perinatal and neonatal conditions on morbidity and mortality outcomes. Interventions of interest include obstetric management strategies (e.g., use of antenatal corticosteroids, mode of delivery), neonatal resuscitation protocols, NICU admission criteria, and the implementation of specific neonatal care practices such as early surfactant administration, infection control measures, and nutritional support.
Behavioral: Infant, Premature
This intervention is distinct as it focuses specifically on observational monitoring and evaluation of neonatal outcomes without applying a therapeutic or procedural treatment. Unlike other interventional studies, the emphasis is on analyzing standard care practices, risk factor exposures (e.g., prematurity, maternal complications), and their impact on neonatal morbidity and mortality. The intervention involves systematic data collection and longitudinal follow-up to identify patterns and associations, rather than introducing new clinical techniques or treatment
Neonatal Mortality Rate
The proportion of neonates who die within the first 28 days of life out of the total number of live births.
Time frame: first 28 days of life
Neonatal Morbidity Incidence
Incidence of major neonatal morbidities, including sepsis, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and perinatal asphyxia.
Time frame: first 28 days of life
Plan to share: Undecided — The database contains sensitive information on neonates and their mothers, protected by ethical and confidentiality regulations. Due to the nature of the data and hospital policies, IPD will not be shared publicly to safeguard patient privacy and comply with local regulations. Aggregated results will be available in scientific publications, but individual data will not be accessible to third parties.
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Sep 2024, 9 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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