NCT03916523: SI-CPAP

Sustained Lung Inflation With CPAP in Preterm Neonates (SI-CPAP)

Completed NA Last updated 18 April 2019

What this trial tests

NA trial testing Sustained lung inflation in RDS of Prematurity in 100 participants. Completed in 15 March 2016.

Timeline

1 January 2013

Primary endpoint
15 March 2016

15 March 2016

Quick facts

Lead sponsor	Ain Shams University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	1 January 2013
Primary completion	15 March 2016
Estimated completion	15 March 2016

Drugs / interventions tested

• Sustained lung inflation
• Continuous positive airway pressure (CPAP)
• Mechanical ventilation

Conditions studied

• RDS of Prematurity — all drugs for RDS of Prematurity →

Sponsor

Ain Shams University

Who can join

Under 6 Hours, any sex, with RDS of Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neonatal respiratory distress syndrome (RDS) is the most common cause of respiratory failure in the first few days in life. It is characterized by the tendency of alveoli and terminal bronchioles to collapse due to the lack of surfactant. RDS is inversely related to gestational age and remains a dominant clinical problem encountered among preterm infants.

The reduction in tidal volume secondary to alveolar collapse may result in alveolar derecruitment, cyclic opening and closing of atelectatic alveoli and distal small airways leading to inflammation and lung injury). On the other hand, the use of high positive end expiratory pressure (PEEP) may be associated with excessive lung parenchyma strain and unfavorable hemodynamic effects. Therefore, lung recruitment maneuvers have been proposed and used to open collapsed lung while managing with low pressure PEEP. However, the best recruitment maneuver technique is currently unknown.

Proinflammatory cytokines are synthesized by alveolar macrophages, type II pneumocytes and other local pulmonary cells causing inflammation that starts a cascade leading to lung injury. Nevertheless, they are released systemically and can lead to injury of other organs.

This study aims to measure inflammatory cytokines in the serum of premature infants who receive and do not receive sustained lung inflation. The study hypothesis is that, in premature infants supported with CPAP, the use of sustained inflation is associated with decreased inflammatory biomarkers and improved respiratory outcomes.

The study includes infants with gestational age of 28-24 weeks during the first 6 hours of life who will be randomly assigned to either receive (or do not receive) sustained inflations. Serum concentrations of cytokines (IL-6, IL-8, IL-1β and TNF-α) will be measured at enrollment and at 96 hours. The primary outcome of this study will be the change in serum cytokine concentrations after intervention in both groups. Clinical respiratory outcomes will be monitored.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.