Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates

NCT ID: NCT07148102

Last Updated: 2025-08-29

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

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-05-01

Brief Summary

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This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates.

Detailed Description

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Non-invasive ventilatory support (NIV) is considered a gold standard care for preterm infants with respiratory distress syndrome (RDS); however, NIV failure remains a frequent challenge that is often associated with many adverse outcomes

Conditions

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Diaphragm Ultrasound Electrical Cardiometry Non Invasive Ventilation (NIV) RDS of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CPAP

30 infants supported by nasal CPAP

Diaphragmatic US

Intervention Type DEVICE

Diaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

EC

Intervention Type DEVICE

TFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

NIPPV

30 infants supported by non-invasive positive pressure ventilation

Diaphragmatic US

Intervention Type DEVICE

Diaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

EC

Intervention Type DEVICE

TFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

NHFOV

30 infants supported with nasal high-frequency oscillatory ventilation

Diaphragmatic US

Intervention Type DEVICE

Diaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

EC

Intervention Type DEVICE

TFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

Interventions

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Diaphragmatic US

Diaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

Intervention Type DEVICE

EC

TFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Preterm neonates of both sexes, with gestational ages ranging from 28 to 34 weeks, diagnosed with RDS and requiring non-invasive ventilation within 30 minutes of birth
Minimum Eligible Age

30 Minutes

Maximum Eligible Age

30 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lamiaa Khaled Zidan

OTHER

Sponsor Role lead

Responsible Party

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Lamiaa Khaled Zidan

Lecturer of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Heba Saied Elmahdy, Professor

Role: STUDY_DIRECTOR

Faculty of Medicine, Tanta University, Tanta, Q2x2+cp Tanta 2, Egypt, 31527

Locations

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Faculty of Medicine, Tanta University

Tanta, Tanta, Q2x2+cp Tanta 2, Egypt, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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DTF, DE, TFC with NIV failure

Identifier Type: -

Identifier Source: org_study_id

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