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

NCT ID: NCT07344714

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome in Premature Infant Transient Tachypnea of the Newborn Meconium Aspiration Syndrome Pneumonia Neonatal Hyaline Membrane Disease Pneumothorax Respiratory Distress Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

41 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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William A. Carey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William A. Carey, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lavonne M. Liedl, LRT

Role: CONTACT

507-255-1828

Facility Contacts

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Lavonne Liedl, LRT

Role: primary

507-255-1828

References

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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.

Reference Type RESULT
PMID: 41458086 (View on PubMed)

Related Links

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Other Identifiers

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24-002867

Identifier Type: -

Identifier Source: org_study_id

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