Clinical trial NCT04107090: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lung ultrasound and diagnosis of respiratory distress syndrome
timeFrame: 1 year
measure: Lung ultrasound and recruitment maneuver
timeFrame: 1 year
measure: Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.
timeFrame: 1 year
measure: Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.
timeFrame: 1 year
measure: Lung ultrasound guided recruitment maneuver and its relation to lung inflammation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Univeristy
Study officials:
References: