Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level

NCT ID: NCT04107090

Last Updated: 2019-09-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2019-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This work is designed to:

1. Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
2. Determine the efficacy of lung ultrasonography in optimizing lung volume and its correlation with pulmonary inflammatory reaction as evidenced by IL-6 level in tracheal aspirate.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The studied population included 44 preterm infants. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

The studied population included 44 preterm infants. Then they were allocated randomly to one of 2 groups in order by admission:

Group A: included 22 patients on whom the recruitment maneuver was applied guided by lung ultrasonography.

Group B: included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.

Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Distress Syndrome, Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was conducted on 44 preterm neonates who were mechanically ventilated for respiratory distress syndrome (RDS). Then they were allocated randomly to one of 2 groups in order by admission:

Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.

Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

US guided lung recruitment

Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.

Group Type EXPERIMENTAL

lung recruitment maneuver

Intervention Type OTHER

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome

tracheal IL-6 level

Intervention Type OTHER

tracheal IL-6 level was measured before and after recruitment maneuver

US guided lung recruitment maneuver

Intervention Type OTHER

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound

Non US guided lung recruitment

Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.

Group Type OTHER

lung recruitment maneuver

Intervention Type OTHER

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome

tracheal IL-6 level

Intervention Type OTHER

tracheal IL-6 level was measured before and after recruitment maneuver

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lung recruitment maneuver

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome

Intervention Type OTHER

tracheal IL-6 level

tracheal IL-6 level was measured before and after recruitment maneuver

Intervention Type OTHER

US guided lung recruitment maneuver

Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Gestational age ≤ 36 weeks.
2. In need for invasive mechanical ventilation for RDS according to Downes Score .

Exclusion Criteria

* excluded:

1. Major upper or lower airway anomalies.
2. Significant congenital anomalies including cardiac, abdominal or respiratory.
3. Surgical cases
4. Inborn errors of metabolism
5. Early onset sepsis.
6. Meconium aspiration syndrome.
7. Hypoxic ischemic encephalopathy.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dina Reda Fikry Kamel

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams Univeristy

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lung Ultrasound

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
NCT06394583 NOT_YET_RECRUITING
Lung Sonar in Neonatal Respiratory Disorders
NCT06292338 NOT_YET_RECRUITING
Lung Ultrasound - Prospective Study
NCT06140615 RECRUITING NA