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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04107090
Enrollment
44
Registered
2019-09-27
Start date
2018-01-20
Completion date
2019-05-20
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

Brief 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.

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.

Interventions

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

OTHERtracheal IL-6 level

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

OTHERUS guided lung recruitment maneuver

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lung ultrasound and diagnosis of respiratory distress syndrome1 yearForty 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 maneuver1 yearAn 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.1 yearThe 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.1 yearThe 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 inflammation1 yearTracheal 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026