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

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lung recruitment maneuver
tracheal IL-6 level
US guided lung recruitment maneuver
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Distress Syndrome, Newborn

Eligibility Criteria

1 Hour - 2 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

US guided lung recruitment

Non US guided lung recruitment

Arm Description

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.

Outcomes

Primary Outcome Measures

Lung ultrasound and diagnosis of respiratory distress syndrome
Forty four preterm neonates diagnosed with respiratoey distress syndrome had lung ultrasound assessment . Its grading was N=normal (presence of lung sliding with A lines or fewer than two isolated B lines) , B1=multiple well-defined B lines , B2=multiple coalescent B lines , C=Consolidation.
Lung ultrasound and recruitment maneuver
An ultrasound re aeration score is calculated from changes in the ultrasound pattern of each region examined during the recruitment maneuver (N,B1,B2,C).
Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .
Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .
Lung ultrasound guided recruitment maneuver and its relation to lung inflammation
Tracheal aspirate IL-6 is measured initially before recruitment maneuver, and on the third day if still ventilated ,or before extubation if done earlier than the third day.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2019
Last Updated
September 25, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04107090
Brief Title
Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level
Official Title
Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This work is designed to: Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US guided lung recruitment
Arm Type
Experimental
Arm Description
Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
Arm Title
Non US guided lung recruitment
Arm Type
Other
Arm Description
Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Intervention Type
Other
Intervention Name(s)
lung recruitment maneuver
Intervention Description
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome
Intervention Type
Other
Intervention Name(s)
tracheal IL-6 level
Intervention Description
tracheal IL-6 level was measured before and after recruitment maneuver
Intervention Type
Other
Intervention Name(s)
US guided lung recruitment maneuver
Intervention Description
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound
Primary Outcome Measure Information:
Title
Lung ultrasound and diagnosis of respiratory distress syndrome
Description
Forty four preterm neonates diagnosed with respiratoey distress syndrome had lung ultrasound assessment . Its grading was N=normal (presence of lung sliding with A lines or fewer than two isolated B lines) , B1=multiple well-defined B lines , B2=multiple coalescent B lines , C=Consolidation.
Time Frame
1 year
Title
Lung ultrasound and recruitment maneuver
Description
An ultrasound re aeration score is calculated from changes in the ultrasound pattern of each region examined during the recruitment maneuver (N,B1,B2,C).
Time Frame
1 year
Title
Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.
Description
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .
Time Frame
1 year
Title
Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.
Description
The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .
Time Frame
1 year
Title
Lung ultrasound guided recruitment maneuver and its relation to lung inflammation
Description
Tracheal aspirate IL-6 is measured initially before recruitment maneuver, and on the third day if still ventilated ,or before extubation if done earlier than the third day.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age ≤ 36 weeks. In need for invasive mechanical ventilation for RDS according to Downes Score . Exclusion Criteria: excluded: Major upper or lower airway anomalies. Significant congenital anomalies including cardiac, abdominal or respiratory. Surgical cases Inborn errors of metabolism Early onset sepsis. Meconium aspiration syndrome. Hypoxic ischemic encephalopathy.
Facility Information:
Facility Name
Ain Shams Univeristy
City
Cairo
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

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

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