NAVA use in preterm neonates with respiratory distress syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares neurally adjusted ventilatory assist (NAVA) to conventional SIMV ventilation in preterm neonates with respiratory distress syndrome who require invasive ventilation. NAVA uses the diaphragm's electrical activity to guide breaths, aiming to improve synchrony between patient effort and ventilator support. Improved synchrony can reduce work of breathing, lower peak airway pressures, and potentially enhance oxygenation while minimizing lung injury. Ventilation is delivered using Maquet Servo-n, Drager, or SLE ventilators, and eligible participants are ≤34 weeks gestation with RDS confirmed clinically and radiologically. The study will enroll neonates admitted to NICUs at Ain Shams University and follow standard safety monitoring and outcome assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Gestational age ≤ 34 weeks.
2. Neonates that have RDS according to clinical and radiological findings
3. Neonates requiring invasive mechanical ventilation.

Exclusion Criteria:

* 1\) Preterm neonates that have respiratory distress due to causes other than respiratory distress syndrome including transient tachypnea of new born , congenital pneumonia and sepsis. 2)Central and peripheral conditions that limit the respiratory drive, as well as diaphragmatic anatomical defects in patients with an intact respiratory drive, comprise the contraindications to NAVA

  * Examples are the following:

    * Central disorder: paralytic drug use, respiratory drive suppression due to heavy sedation or brain injury.
    * Peripheral disorder: phrenic nerve injury, paralytic agent administration.
    * Structural (anatomical) disorder: esophageal atresia, diaphragmatic hernia. 3) Cardiac patients including aortic coarctation , double outlet right ventricle (DORV), Tetralogy of Fallot and Transposition of the great arteries (TGA). 4) Surgical patients including gastroschisis , omphalocele , tracheoesophageal fistula and congenital diaphragmatic hernia (CDH).

Where it's running

• Neonatal Intensive Care Units (NICUs), Ain Shams University
  Cairo, Abbasia, Egypt Recruiting

Study contacts

• Study coordinator: Rania Ali El-Farrash
• Phone: +201222208550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.