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NCT Number: 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

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.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

1 hour–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Univeristy

Cairo, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age ≤ 36 weeks.
  • In need for invasive mechanical ventilation for RDS according to Downes Score .

Exclusion criteria

  • excluded:
  • Major upper or lower airway anomalies.
  • Significant congenital anomalies including cardiac, abdominal or respiratory.
  • Surgical cases
  • Inborn errors of metabolism
  • Early onset sepsis.
  • Meconium aspiration syndrome.
  • Hypoxic ischemic encephalopathy.

Treatment and study plan

Lung Recruitment Maneuver

Other

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

tracheal IL-6 level

Other

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

US guided lung recruitment maneuver

Other

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

Primary outcomes

  1. Lung ultrasound and diagnosis of respiratory distress syndrome

    Time frame: 1 year

    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.

  2. Lung ultrasound and recruitment maneuver

    Time frame: 1 year

    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).

  3. Lung ultrasound guided recruitment maneuver and the period of oxygen dependency.

    Time frame: 1 year

    The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring oxygen therapy in the NICU .

  4. Lung ultrasound guided recruitment maneuver and the total number of NICU admission days.

    Time frame: 1 year

    The relation between early lung recruitment maneuver guided by lung ultrasound and how many days requiring admission in the NICU .

  5. Lung ultrasound guided recruitment maneuver and its relation to lung inflammation

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2019
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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