Preterm BirthUCENCT06653374
Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns
An observational study of Preterm Birth and Low Birth Weight, run by HOSPITAL GINECO OBSTETRICO ISIDRO AYORA at 1 site in Ecuador.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Preterm Birth, Low Birth Weight, Intrauterine Growth Restriction (IUGR)
- What is being tested?
- Infant, Premature
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26,000 participants
- Where
- 1 siteEcuador
- Study dates
- 12 Nov 2023to 10 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Hospital Gineco Obstétrico Isidro Ayora
Quito, Pichincha, 170601
About this study
Official title: "Condiciones Perinatales Que Influyen en la Morbimortalidad y atención Medica en Neonatos Del Hospital Gineco Obstétrico Isidro Ayora, Enero 2008-diciembre 2022"
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.
Read the detailed description
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
- Preterm Birth, Low Birth Weight, Intrauterine Growth Restriction (IUGR), Perinatal Asphyxia, Neonatal Sepsis, Respiratory Distress Syndrome (RDS)
- Being tested
- Infant, Premature
- 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
- Medical subject headings
- Premature Birth, Fetal Growth Retardation, Neonatal Sepsis, Respiratory Distress Syndrome, Jaundice, Neonatal, Congenital Abnormalities, Diabetes, Gestational, Abruptio Placentae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant, PrematureBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Infant, Premature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Mortality Rate
The proportion of neonates who die within the first 28 days of life out of the total number of live births.
Measured: first 28 days of life
Secondary outcomes (1)
Neonatal Morbidity Incidence
Incidence of major neonatal morbidities, including sepsis, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and perinatal asphyxia.
Measured: first 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start12 Nov 2023
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 26,000 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653374
- Sponsor's protocol ID
- 009-DOC-FCM-2023
- Other IDs
- 009-DOC-FCM-2023
- Acronym
- UCE
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The database contains sensitive information on neonates and their mothers, protected by ethical and confidentiality regulations. Due to the nature of the data and hospital policies, IPD will not be shared publicly to safeguard patient privacy and comply with local regulations. Aggregated results will be available in scientific publications, but individual data will not be accessible to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Condiciones Perinatales Que Influyen en la Morbimortalidad y atención Medica en Neonatos Del Hospital Gineco Obstétrico Isidro Ayora, Enero 2008-diciembre 2022"
- ClinicalTrials.gov ID
- NCT06653374
- Acronym / sponsor ID
- UCE / 009-DOC-FCM-2023
- Conditions
- Preterm Birth, Low Birth Weight, Intrauterine Growth Restriction (IUGR), Perinatal Asphyxia, Neonatal Sepsis, Respiratory Distress Syndrome (RDS)
- Keywords
- Infant, Premature, Infant, Low Birth Weight, Fetal Growth Retardation, Asphyxia Neonatorum, Sepsis, Neonatal, Respiratory Distress Syndrome, Newborn, Jaundice, Neonatal, Congenital Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,000 participants (actual)
- Lead sponsor
- HOSPITAL GINECO OBSTETRICO ISIDRO AYORAUniversity, hospital or other
- Collaborators
- Universidad Central del Ecuador
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 22 Oct 2024 (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.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant, Premature | – | Behavioral: Infant, PrematureThe "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. |
| Neonatal Morbidity and Mortality Cohort | – | Behavioral: Infant, PrematureThis 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. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant, PrematureThis 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 | Behavioural | Infant, Premature, Neonatal Morbidity and Mortality Cohort |
Primary outcome
Neonatal Mortality Rate
Time frame: first 28 days of life
The proportion of neonates who die within the first 28 days of life out of the total number of live births.
1 secondary outcome
Neonatal Morbidity Incidence
Time frame: first 28 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Undecided. The database contains sensitive information on neonates and their mothers, protected by ethical and confidentiality regulations. Due to the nature of the data and hospital policies, IPD will not be shared publicly to safeguard patient privacy and comply with local regulations. Aggregated results will be available in scientific publications, but individual data will not be accessible to third parties.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preterm Birth and Low Birth Weight, 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 4 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: finished, as of the sponsor's last update on 22 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Mortality Rate (time frame: first 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2024.