Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns

NCT ID: NCT06653374

Last Updated: 2024-10-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

26000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-12

Study Completion Date

2024-09-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preterm Birth Low Birth Weight Intrauterine Growth Restriction (IUGR) Perinatal Asphyxia Neonatal Sepsis Respiratory Distress Syndrome (RDS) Neonatal Jaundice Congenital Malformations Neonatal Hypoglycemia Gestational Diabetes Mellitus (GDM) Placental Abruption Preterm Premature Rupture of Membranes (PPROM) Hypertension, Pregnancy-Induced Pre-Eclampsia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Neonates born at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022.
* 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 with incomplete or missing medical records.
* 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.
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Central del Ecuador

OTHER

Sponsor Role collaborator

HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

OTHER

Sponsor Role lead

Responsible Party

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Santiago Vasco-Morales

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Gineco Obstétrico Isidro Ayora

Quito, Pichincha, Ecuador

Site Status

Countries

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Ecuador

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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