Neonatal Respiratory Failure Clinical Trial
— VNINSOfficial title:
Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | June 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 14 Days |
Eligibility |
Inclusion Criteria: - Preterm with a weight less than 1501 g - Gestational age less or equal to 34 weeks - Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation - Patient receiving methylxanthynes Exclusion Criteria: - Patient more than 14 days in mechanical ventilation - Newborn with congenital cardiopathy - Newborn with congenital malformation - Newborn wirh chromosomopathy or genopathic disease - Newborn with suspected gastrointestinal disease - Newborn with neuromuscular disease or receiving muscle relaxants - Lack or informed consent signed by parents or legal representative |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clinico, Pontificia Universidad Catolica de Chile | Santiago |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extubation failure | The criteria for failure were met by at least 1 of the following: pH less than 7.25 and PaCO2 over 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 less than 50 mm Hg with a fraction of inspired oxygen over 0.6. |
apnea rate and respiratory failure. | Yes |
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