Recruiting NCT07344714

Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting

— Observational Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome in Premature Infant Transient Tachypnea of the Newborn Meconium Aspiration Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant, Transient Tachypnea of the Newborn, Meconium Aspiration Syndrome. Basic parameters: 32 Weeks — 41 Weeks · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting

Overview

The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (\>6 hours of life).

Detailed description

The source of the gastric aspirates will be the medical waste generated through the routine care of neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.

Primary outcome measures

Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life. [Time frame: 1 years]
Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

Both of the following:

Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated
Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization.

Exclusion criteria

Any one of the following:

Neonates with known or suspected congenital anomalies
Neonates for whom only comfort measures are planned or possible at time of delivery
Neonates whose parents actively declined the Minnesota Research Authorization.
Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Cohort

Study locations

United States · 1 center

Mayo Clinic in Rochester — Rochester

Publications

Leigh BC, Liedl LM, Amsbaugh AL, Carey WA. Spectral analysis of gastric aspirates obtained shortly after birth predicts the need for prolonged respiratory support in neonates in a development cohort. Front Pediatr. 2025 Dec 11;13:1686794. doi: 10.3389/fped.2025.1686794. eCollection 2025. PMID 41458086

Identifiers

NCT: NCT07344714 · 24-002867

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗