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

NCT06653374 — Completed, 26000 participants, HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

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"Condiciones Perinatales Que Influyen en la Morbimortalidad y atención Medica en Neonatos Del Hospital Gineco Obstétrico Isidro Ayora, Enero 2008-diciembre 2022"

Registry	NCT06653374, acronym UCE
Status	Completed
Study type	Observational
Enrollment	26000 (Actual)
Sponsor	HOSPITAL GINECO OBSTETRICO ISIDRO AYORA (Other); collaborators: Universidad Central del Ecuador
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
Interventions	Infant, Premature (Behavioral)
Dates	start 2023-11-12, primary completion 2024-09-10, completion 2024-09-10, first posted 2024-10-22, last updated 2024-10-22
Locations	1 site in Ecuador

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Infant, Premature		Behavioral: 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.
Neonatal Morbidity and Mortality Cohort		Behavioral: Infant, Premature	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.

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

+Outcome measures

Primary outcomes

Neonatal Mortality Rate [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.

Secondary outcomes

Neonatal Morbidity Incidence [first 28 days of life]: Incidence of major neonatal morbidities, including sepsis, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and perinatal asphyxia.

+Eligibility

Sex: All, ages: any to 28 Days

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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\&#39;s database.

+Locations (1)

Facility	City	Country	Status
Hospital Gineco Obstétrico Isidro Ayora	Quito, Pichincha	Ecuador