Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress

Launched by INDONESIA UNIVERSITY · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new method called High Velocity Nasal Insufflation (HVNI) for helping preterm infants who are experiencing moderate breathing difficulties, known as respiratory distress. Traditionally, a treatment called Continuous Positive Airway Pressure (CPAP) is used, but it can sometimes cause discomfort and other issues for the babies. The goal of this study is to see if HVNI can work just as well as CPAP without causing the same problems.

To participate in this trial, infants must be born prematurely (before 32 weeks of pregnancy) or weigh less than 1500 grams at birth and show signs of moderate respiratory distress shortly after birth. Parents must also agree to take part in the study. If enrolled, babies will be randomly assigned to receive either HVNI or CPAP for their treatment. The researchers will monitor how well each method works over 72 hours to determine which is more effective. This study aims to provide valuable information that could improve care for premature infants with breathing difficulties.

Gender

ALL

Eligibility criteria

• • \*\*Inclusion Criteria:\*\*
• • Preterm infants born in Cipto Mangunkusumo Hospital with gestational age (GA) less than 32 weeks or birth weight less than 1500 grams.
• • Infants with moderate respiratory distress (Downe score ≤ 6) detected within 24 hours after birth.
• • Parents are willing to participate in the study.
• • \*\*Exclusion Criteria:\*\*
• • Infants with severe respiratory distress (Downe score ≥ 6) requiring invasive treatment in the form of mechanical ventilation, or apnea indicated by surfactant administration via endotracheal tube.
• • Infants with contraindications to the use of non-invasive ventilation such as esophageal atresia, diaphragmatic hernia, air leak syndrome, and other conditions.
• • Infants with respiratory distress due to non-pulmonary abnormalities.
• • Infants with congenital metabolic disorders.
• • Infants with congenital abnormalities that exacerbate respiratory distress.