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

Respiratory Distress Syndrome, Newborn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107090
• Other study ID #: Lung Ultrasound
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: May 20, 2019

Study information

• Verified date: September 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 20, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• lung recruitment maneuver
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome
• tracheal IL-6 level
tracheal IL-6 level was measured before and after recruitment maneuver
• US guided lung recruitment maneuver
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound

Locations

Country	Name	City	State
Egypt	Ain Shams Univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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).	1 year
Primary	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 .	1 year
Primary	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 .	1 year
Primary	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.	1 year