asal Intermittent Positive Pressure Ventilatio

Completed

• Conditions: Bronchopulmonary dysplasia; Pregnancy and Childbirth; Respiratory distress of newborn

• Registration Number: ISRCTN15233270
• Lead Sponsor: McMaster University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Group A: complete obstetric and neonatal history and a clinical examination are required to confirm eligibility, however, results of study-specific laboratory or radiological investigations are not required to judge patient eligibility.
1. Gestational age at birth less than 30 weeks, either sex
2. Birthweight 999 grams or less
3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
Group B: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
OR
Group B: the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.

Exclusion Criteria

1. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus)
2. Infants known to require surgical treatment, e.g. congenital diaphragmatic hernia, trache-oesophageal fistula, omphalocele, gastroschisis
3. Abnormalities of the upper and lower airways such as Pierre-Robin sequence, Treacher-Collins syndrome, Goldenhar syndrome, cleft lips and palate
4. Neuromuscular disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified