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

NCT06653374 | Completed

• 1 other identifier: 009-DOC-FCM-2023
• Study Type: observational
• Target: 26,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Infant, Premature; Infant, Low Birth Weight; Fetal Growth Retardation; Asphyxia Neonatorum; Sepsis, Neonatal; Respiratory Distress Syndrome, Newborn; Jaundice, Neonatal; Congenital Abnormalities; Hypoglycemia, Neonatal; Hypertension, Pregnancy-Induced; Diabetes, Gestational; Placental Abruption; Premature Rupture of Fetal Membranes

Outcome Measures

Primary Outcomes (1)

• Neonatal Mortality Rate

  The proportion of neonates who die within the first 28 days of life out of the total number of live births.

  first 28 days of life

Secondary Outcomes (1)

• Neonatal Morbidity Incidence

  first 28 days of life

Study Arms (2)

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.

Behavioral: Infant, Premature

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.

Behavioral: Infant, Premature

Interventions

Infant, Premature 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

Infant, Premature; Neonatal Morbidity and Mortality Cohort

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HOSPITAL GINECO OBSTETRICO ISIDRO AYORA: lead
• Universidad Central del Ecuador: collaborator

Study Sites (1)

Hospital Gineco Obstétrico Isidro Ayora

Quito, Pichincha, 170601, Ecuador

Location

MeSH Terms

Conditions

Premature Birth; Fetal Growth Retardation; Neonatal Sepsis; Respiratory Distress Syndrome; Jaundice, Neonatal; Congenital Abnormalities; Diabetes, Gestational; Abruptio Placentae; Preterm Premature Rupture of the Membranes; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Asphyxia Neonatorum; Respiratory Distress Syndrome, Newborn; Hypoglycemia; Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Infant, Newborn, Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Placenta Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 22, 2024
• Study Start: November 12, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

EC (1)