Analysis on the Health of Newborns in Three Hospitals, 2008-2024

December 27, 2024 updated by: Santiago Vasco-Morales, HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

Multicenter Analysis of Morbidity, Mortality and Medical Care in Neonates At the Isidro Ayora Gynecological-Obstetric Hospital, the Calderón General Teaching Hospital and the Nueva Aurora Luz Elena Arismendi Pediatric Gynecological-Obstetric Hospital, January 2008-June 2024

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 2022 to December 2023. 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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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 2022 to December 2023 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.

Study Type

Observational

Enrollment (Actual)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador, 170601
        • Hospital Gineco Obstétrico Isidro Ayora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Definition: This group includes neonates admitted to HGOIA, HGDC, and HGONA between January 2008 and

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Morbidity and Mortality Rate
Time Frame: 14 years

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.
14 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Intrauterine Growth Disorders (Low Birth Weight and Macrosomia)
Time Frame: 14 years

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.
14 years
Incidence of Prematurity-Related Complications
Time Frame: 14 years

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.
14 years
Comparison of Indicators Across Hospitals
Time Frame: 14 years

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.
14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

Collaborators

Universidad Central del Ecuador

Investigators

  • Study Director: Elina Yanez Valencia, Neonatologa, Hospital Docente de Calderon
  • Principal Investigator: Monica Diaz Torres, Neonatologa, Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

November 12, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEISH-HGDC-2024-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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