Respiratory Distress Syndrome Clinical Trial
— NICAOfficial title:
Nasal Intermittent Positive Pressure Ventilation vs. Nasal Continuous Positive Airway Pressure at Equivalent Mean Airway Pressure in Preterm Infants: Effect on Oxygenation, CO2 Elimination, Work of Breathing and Frequency of Cardio-respiratory Events.
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility |
Inclusion Criteria: - Gestational Age 23-34 completed weeks - Stable on non- invasive respiratory support for at least 24h - CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O - FiO2 requirement of <0.40 Exclusion Criteria: - Clinical instability as judged by the clinical team - FiO2 requirement of > 0.40 for more than 60 min. - >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation. - Anticipated intubation within next 24 h. - Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction). - Hemodynamically significant patent ductus arteriosus (PDA) - Anticipated weaning off non-invasive support in the next 24 h. - Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias - Lack of study equipment or personnel - Lack of parental consent |
Country | Name | City | State |
---|---|---|---|
United States | Women and Infants Hospital of Rhode Island | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Apnea/bradycardia events | Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor | Duration of intervention (12 hours) | |
Secondary | Number of of desaturation events | Number of episodes of pulse oximetry readings that trigger alarm on the bedside monitor | Duration of intervention (12 hours) | |
Secondary | Mean oxygen saturation by pulse oximetry and proportion of time below 88% | Mean oxygen saturation by pulse oximetry and proportion of time at saturation <88% | Duration of intervention (12 hours) | |
Secondary | Mean transcutaneous PCO2 and proportion of time >55 torr | Mean transcutaneous PCO2 and proportion of time at PCO2 > 55 torr | Duration of intervention (12 hours) | |
Secondary | Mean fraction of inspired oxygen | Mean fraction of inspired oxygen (FIO2) | Duration of intervention (12 hours) | |
Secondary | Mean respiratory rate | Mean respiratory rate | Duration of intervention (12 hours) | |
Secondary | Mean degrees of phase lag by RIP | Estimate of work of breathing based on phase angle as determined by respiratory inductive plethysmography | Duration of intervention (12 hours) | |
Secondary | Number of episodes of feeding intolerance | number of instances of interruption of feeding, abdominal radiographs | Duration of intervention (12 hours) | |
Secondary | Instances of treatment failure | Inability to tolerate assigned treatment by pre-defined criteria | Duration of intervention (12 hours) |
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