Neonatal Morbidity and MortalityNCT06758622
Analysis on the Health of Newborns in Three Hospitals, 2008-2024
An observational study of Neonatal Morbidity and Mortality and Intrauterine Growth Disorders (IUGR and Macrosomia), run by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA at 1 site in Ecuador.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia), Prematurity Complications
- How many people
- 40,000 participants
- Where
- 1 siteEcuador
- Study dates
- 9 Nov 2024to 10 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Hospital Gineco Obstétrico Isidro Ayora
Quito, Pichincha, 170601
About this study
Official title: 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 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?
Read more
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.
Read the 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 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.
- Conditions
- Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia), Prematurity Complications, Neonatal Infections
- Keywords
- Neonatal Mortality, Neonatal Morbidity, Infant, Low Birth Weight
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Definition: This group includes neonates admitted to HGOIA, HGDC, and HGONA between January 2008 and | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start9 Nov 2024
- Primary completion12 Nov 2025
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Morbidity and MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 40,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Central del Ecuador
- Responsible party
- Principal investigator, Santiago Vasco-Morales, HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
- Investigators
- Elina Yanez Valencia, Neonatologa, Study director, Hospital Docente de CalderonMonica Diaz Torres, Neonatologa, Principal investigator, Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758622
- Sponsor's protocol ID
- CEISH-HGDC-2024-007
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosero-Quintana MD, Vasco-Morales S, Benalcazar-Sanmartin K, Salazar-Congacha LP, Toapanta-Pinta PC. Frequency of episiotomy practice in an institution in Quito, Ecuador 2009-2022. Rev Colomb Obstet Ginecol. 2024 Jul 9;75(2):4216. doi: 10.18597/rcog.4216. English, Spanish.
PubMed 39470265
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06758622
- Acronym / sponsor ID
- CEISH-HGDC-2024-007
- Conditions
- Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia), Prematurity Complications, Neonatal Infections
- Keywords
- Neonatal Mortality, Neonatal Morbidity, Infant, Low Birth Weight
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40,000 participants (actual)
- Lead sponsor
- HOSPITAL GINECO OBSTETRICO ISIDRO AYORAUniversity, hospital or other
- Collaborators
- Universidad Central del Ecuador
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definition: This group includes neonates admitted to HGOIA, HGDC, and HGONA between January 2008 and | – | – |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Prevalence of Intrauterine Growth Disorders (Low Birth Weight and Macrosomia)
Time frame: 14 years
Incidence of Prematurity-Related Complications
Time frame: 14 years
Comparison of Indicators Across Hospitals
Time frame: 14 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 39470265Rosero-Quintana MD, Vasco-Morales S, Benalcazar-Sanmartin K, Salazar-Congacha LP, Toapanta-Pinta PC. Frequency of episiotomy practice in an institution in Quito, Ecuador 2009-2022. Rev Colomb Obstet Ginecol. 2024 Jul 9;75(2):4216. doi: 10.18597/rcog.4216. English, Spanish.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elina Yanez Valencia, Neonatologa study director
Hospital Docente de Calderon
Monica Diaz Torres, Neonatologa principal investigator
Hospital Gineco Obstétrico Pediátrico de Nueva Aurora Luz Elena Arismendi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Morbidity and Mortality and Intrauterine Growth Disorders (IUGR and Macrosomia), run by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Morbidity and Mortality Rate (time frame: 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.