Ireland
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Recruiting Not applicable

NAVA Use in Preterm Neonates With Respiratory Distress Syndrome

NCT07926009 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-01-24
Last updated
2026-11-09

Condition(s) studied

Preterm , Respiratory Distress SyndromePreterm Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Maquet [servo-n]Drager , SLE 5000, SLE 6000

Maquet [servo-n]: ventilator settings will be recorded such as: NAVA level , Edi peak , peep, apnea time

Drager , SLE 5000, SLE 6000: ventilator settings will be recorded such as peep , PIP , Fio2

Study summary

A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome.

Eligibility

Sex
ALL
Min age
1 Day
Max age
1 Month
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Echocardiography — baseline and after 24 hours from enrollment in the study
    to assess any structural cardiac anomalies, the patency of ductus arteriosus, right ventricular output (RVO), left ventricular output (LVO), and superior vena cava (SVC) flow, ejection fraction (EF) and pulmonary pressure performed by a specialized echocardiographist.

Trial sites (1)

FacilityCityRegionStatus
Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo Abbasia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07926009 on ClinicalTrials.gov ↗ ← All trials in Egypt