An observational study in Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia) and Prematurity Complications, sponsored by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA. Active, not recruiting at 1 site in Ecuador. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA · Observational
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 2008 to June 2024. 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.
Detailed Description of the Study
This retrospective observational study aims to analyze the factors associated with neonatal morbidity and mortality in three hospitals in Quito, Ecuador: the Hospital Gineco Obstétrico Isidro Ayora (HGOIA), the Hospital General Docente de Calderón (HGDC), and the Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi (HGONA). The study spans the period from January 2008 to June 2024 and utilizes secondary data obtained from the Perinatal Information System (SIP) and the Maternal-Perinatal Clinical Record (HCMP).
Background and Rationale:
The analysis of perinatal factors related to neonatal morbidity and mortality is crucial to improving neonatal care standards and reducing mortality rates. According to the Ecuadorian Ministry of Public Health, the main causes of neonatal mortality in 2020 included prematurity, respiratory distress syndrome, and congenital anomalies, among others. This study seeks to identify and quantify risk and protective factors in the neonatal population admitted to the three mentioned hospitals, enabling the design of more effective interventions.
Methodology:
A cross-sectional design with retrospective data collection will be utilized. The study participants will include all neonates recorded in the SIP and HCMP databases during the specified period. Data will encompass perinatal variables such as birth weight, gestational age, congenital anomalies, neonatal complications, and maternal conditions (e.g., age, comorbidities).
Procedures:
Data Collection:
Extraction of relevant information from the SIP and HCMP databases. Identification and removal of duplicate or incomplete records. Organization of variables using an operationalization chart detailing dimensions, indicators, and measurement scales.
Statistical Analysis:
Bivariate and multivariate analyses will be conducted using logistic regression models to evaluate associations between variables.
Odds ratios (OR) with 95% confidence intervals will be calculated. Neonatal growth curves stratified by sex and gestational age will be generated. R software will be used for all statistical analyses.
Expected Outcomes:
Identification of risk and protective factors associated with neonatal morbidity and mortality.
Characterization of intrauterine growth disorders, prematurity complications, and congenital anomalies in the studied population.
Comparison of indicators across the three hospitals to identify significant differences and design improvement strategies.
Limitations:
Potential biases are anticipated, including errors in clinical record documentation and incomplete data. These limitations will be addressed through thorough data cleaning and exclusion of inconsistent records.
Expected Impact:
The findings will contribute to the development of evidence-based neonatal clinical care protocols and guidelines, aiming to reduce morbidity and mortality rates in participating hospitals and serve as a model for other institutions in the country.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's enrollment of 40,000 is above the median of 200 across 145 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation 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 consists of neonates born between January 2022 and December 2023 at three hospitals in Quito, Ecuador: Hospital Gineco Obstétrico Isidro Ayora, Hospital General Docente de Calderón, and Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi. These neonates must have complete perinatal medical records documented in the Perinatal Information System or the Maternal-Perinatal Clinical Record.
The population includes neonates with varying birth weights, gestational ages, and neonatal complications, as well as their associated maternal conditions, such as age, comorbidities, and pregnancy outcomes. The study focuses on analyzing the prevalence of morbidity and mortality, growth disorders (low birth weight and macrosomia), prematurity-related complications, and adherence to neonatal care interventions like the Kangaroo Mother Care program and Human Milk Bank services.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Neonatal Morbidity and Mortality Rate
Definition: Proportion of neonates experiencing morbidity (severe diseases or complications) or mortality within the first 28 days of life. Method of Measurement: Calculation of rates and proportions using Perinatal Information System and Maternal perinatal medical records. Unit of Measure: Percentage (%) per 1000 live births. Time Frame: From birth to 28 days of life.
Time frame: 14 years
Prevalence of Intrauterine Growth Disorders (Low Birth Weight and Macrosomia)
Definition: Proportion of neonates born with birth weight below 2500 grams (low birth weight) or over 4000 grams (macrosomia). Method of Measurement: Analysis of birth weight data using Perinatal Information System and Maternal perinatal medical records. Unit of Measure: Percentage (%). Time Frame: At birth.
Time frame: 14 years
Incidence of Prematurity-Related Complications
Definition: Frequency of complications such as bronchopulmonary dysplasia, retinopathy of prematurity, and intraventricular hemorrhage. Method of Measurement: Identification of diagnoses in clinical records. Unit of Measure: Percentage (%). Time Frame: From birth to 28 days of life.
Time frame: 14 years
Comparison of Indicators Across Hospitals
Definition: Significant differences in morbidity, mortality, and complication rates among the three hospitals. Method of Measurement: Multivariate statistical analysis. Unit of Measure: Odds ratio (OR) with 95% confidence intervals. Time Frame: Entire study period.
Time frame: 14 years
Plan to share: No
Ran from Nov 2024 to primary completion in Nov 2025, 12 months.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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