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NCT07216053 · ClinicalTrials.gov registry record
Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
A clinical trial of Premature and Pre-Term, sponsored by Hackensack Meridian Health.
- Recruiting
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT07216053: Recruiting study of Premature and Pre-Term, sponsored by Hackensack Meridian Health.
NCT07216053 is a study of Premature and Pre-Term that is actively recruiting participants, run by Hackensack Meridian Health. The registered enrollment target is 300 participants, above the 160-participant average among 4 other Premature trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216053, a study of Premature and Pre-Term, is actively recruiting participants, sponsored by Hackensack Meridian Health.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate. With this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.
Primary Outcome
The binary outcome of escalation vs non-escalation of respiratory support will be used to predict the accuracy of the three established POC LUS scoring systems (Three type-of-lung, Full LUS, high-risk pattern assessment) for identifying late preterm infants who experience respiratory decompensation. Respiration decompensation is defined by need for respiratory support in the form of HFNC (high flow nasal cannula), CPAP (continuous positive airway pressure), NIMV (non-invasive mechanical ventilat
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Point of care lung ultrasound
Study Locations (1)
New Jersey
- Hackensack Univeristy Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-11-06 |
| Est. Completion | 2027-11 |
What NCT07216053 shows while recruiting
NCT07216053 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 160-participant average among 4 other Premature trials with a reported enrollment target (88% higher).
The record links to 3 conditions, with Premature appearing as the primary indexed condition, and to 1 intervention - of which Point of care lung ultrasound is the first listed.
NCT07216053 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07216053 about?
NCT07216053 is a clinical study titled "Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates". Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity,...
What is the current status of trial NCT07216053?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2025-11-06. Estimated completion is 2027-11.
What conditions does trial NCT07216053 study?
This clinical trial studies the following conditions: Premature, Pre-Term, Respiratory Distress of Newborn.
What interventions are being tested in trial NCT07216053?
The interventions under investigation include: Point of care lung ultrasound (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07216053?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216053 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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