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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

A

Ain Shams University

Status

Completed

Conditions

Respiratory Distress Syndrome, Newborn

Treatments

Other: lung recruitment maneuver
Other: tracheal IL-6 level
Other: US guided lung recruitment maneuver

Study type

Interventional

Funder types

Other

Identifiers

NCT04107090
Lung Ultrasound

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

1 hour to 2 days old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

US guided lung recruitment
Experimental group
Description:
Group A: it included 22 patients on whom the recruitment manoeuvre was applied guided by lung ultrasonography.
Treatment:
Other: US guided lung recruitment maneuver
Other: lung recruitment maneuver
Other: tracheal IL-6 level
Non US guided lung recruitment
Other group
Description:
Group B: it included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.
Treatment:
Other: lung recruitment maneuver
Other: tracheal IL-6 level

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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