asal Intermittent Positive Pressure Ventilation for Premature Infants

Phase 3

Completed

• Conditions: Bronchopulmonary dysplasia; Chronic Lung Disease; Respiratory Distress; 10028971

• Registration Number: NL-OMON32906
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

Gestational age less than 30 weeks
Birthweight less than 1 kg
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube) whether
A. primairy: within the first 7 days of life and the infant has never been intubated or has received less than 24 hours of intubated respiratory support (e.g. for endotracheal surfactant therapy /INSURE:intubate-surfactant replacement therapy-extubate)
OR
B. secondary:the infant is within the first 28 days of life, has been managed with intubated respiratory support for more than 24 hours and is a candidate for extubation followed by non-invasive respiratory support.

Exclusion Criteria

1. Considered Non-viable by attending physician
2. Life-threatening congenital abnormalties including congenital heart disease (exl patent ductus arteriosus)
3. Infants known to require surgical treatmene e.g. congenital diaphragmatic hernia, tracheo-oesophageal fistula, omphalocele and gastroschisis.
4. Abnormalties of the upper and lower airways; such as Pierre-Robin sequence, Treacher Collins syndrome, Goldenhar syndrome, cleft lips and palate.
5. Neuromuscular disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified