Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns
NCT ID: NCT06653374
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26000 participants
OBSERVATIONAL
2023-11-12
2024-09-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Infant, Premature
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.
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 Morbidity and Mortality Cohort
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Live-born neonates with complete medical records in the hospital's perinatal database.
* Neonates whose mothers received antenatal care and delivered at the hospital. Availability of maternal and neonatal data, including gestational age, birth weight, and outcome information.
Exclusion Criteria
* Neonates born outside the hospital and referred postnatally.
* Stillbirths and pregnancies terminated due to maternal or fetal indications.
* Neonates discharged to other facilities immediately after birth without follow-up data in the hospital\'s database.
28 Days
ALL
No
Sponsors
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Universidad Central del Ecuador
OTHER
HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
OTHER
Responsible Party
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Santiago Vasco-Morales
Principal Investigator
Locations
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Hospital Gineco Obstétrico Isidro Ayora
Quito, Pichincha, Ecuador
Countries
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Other Identifiers
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009-DOC-FCM-2023
Identifier Type: OTHER
Identifier Source: secondary_id
009-DOC-FCM-2023
Identifier Type: -
Identifier Source: org_study_id
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