Can 16 years of birth records reveal how to save more newborns?

NCT ID NCT06758622

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study looks back at medical records from about 40,000 newborns admitted to three hospitals in Quito, Ecuador, between 2008 and 2024. The goal is to understand which factors—like birth weight, gestational age, birth defects, and mother's health—are linked to newborn illness or death within the first 28 days of life. By analyzing this data, researchers hope to identify patterns that can guide better care and create growth charts tailored to this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
This could identify key risk factors for newborn complications and death, leading to better care protocols and growth standards for hospitals in Ecuador and similar settings.
What could go wrong
As an observational study, it can show associations but not prove cause and effect. Data quality and completeness from past records may vary, and findings may not apply to other regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40,000 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Gineco Obstétrico Isidro Ayora

    Quito, Pichincha, 170601, Ecuador

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