An interventional study of lung recruitment maneuver and tracheal IL-6 level in Respiratory Distress Syndrome, Newborn, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 1 Hour to 2 Days. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Ain Shams University · Not applicable, Interventional, and Other
This work is designed to:
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
excluded:
Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
Other: lung recruitment maneuver · Other: tracheal IL-6 level · Other: US guided lung recruitment maneuver
Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Other: lung recruitment maneuver · Other: tracheal IL-6 level
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome
tracheal IL-6 level was measured before and after recruitment maneuver
Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound
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.
Time frame: 1 year
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).
Time frame: 1 year
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 .
Time frame: 1 year
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 .
Time frame: 1 year
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.
Time frame: 1 year
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Ain Shams University