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Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants

NCT ID: NCT05726578

Last Updated: 2025-05-28

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

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-01

Brief Summary

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The primary aim of this work is to evaluate the role of high frequency oscillatory ventilation (HFOV) in recruitment of lung in preterm newborns 32 to 37 weeks gestational age with moderate to severe respiratory distress. The secondary aim is to evaluate the role of chest ultrasound in monitoring of lung recruitment in comparison to routine chest x ray in those babies. Also cardiac hemodynamics will be assesed using functional echocardiography.

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Detailed Description

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Conditions

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Ventilator Lung Echocardiography Chest Ultrasound High Frequency Ventilation Lung Recruitment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lung recruitment

preterm infants with moderate to severe respiratory distress

Group Type EXPERIMENTAL

Lung recruitment

Intervention Type OTHER

establishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography

Interventions

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Lung recruitment

establishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants will be enrolled if they are 32 to 37 weeks of gestational age, have respiratory distress (RD) in the first 24 h of life, intubated and have invasive respiratory support using HFOV. Signs of RD are tachypnea (respiratory rate \> 60/min), grunting, nasal flaring, chest retraction, and need of oxygen supplementation or other respiratory support.

Exclusion Criteria

1. Known major congenital anomalies including congenital heart diseases.
2. Fetal hydrops.
3. Babies with congenital heart diseases
Minimum Eligible Age

1 Hour

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Hazem Wagih Gouda, PhD

Role: STUDY_CHAIR

Alexandria University

Ali Mohamed Abd Almohsen, PhD

Role: STUDY_DIRECTOR

Alexandria University

Locations

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Marwa Mohamed Farag

Alexandria, , Egypt

Site Status RECRUITING

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, , Egypt

Site Status NOT_YET_RECRUITING

Countries

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Egypt

Central Contacts

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Marwa M Farag, PhD

Role: CONTACT

[email protected]
01288681788 ext. +2

Mohamed Hany Saad, MBBCh

Role: CONTACT

[email protected]
01282226826 ext. +2

Facility Contacts

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Marwa M Farag, phD

Role: primary

[email protected]
01288681788

Marwa M Farag, PhD

Role: primary

[email protected]
01009795810 ext. +2

Other Identifiers

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0201752

Identifier Type: -

Identifier Source: org_study_id

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