Apnea of Prematurity, Prematurity, Respiratory Distress Syndrome
Conditions
Keywords
Continuous positive airway pressure, Nasal intermittent positive pressure ventilation, Mean airway pressure, Apnea, Bradycardia, Prematurity
Brief summary
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.
Detailed description
This is a pilot clinical trial to evaluate the comparative effectiveness of two commonly used types of non-invasive respiratory support. Preterm infants \< 34 weeks gestational age, who are stable on either of the two modalities of support will be studied in a cross-over study design, such that each subject acts as his/her own control. The study will assess the relative efficacy of these modalities when used with equal mean airway pressure comparing measures of oxygenation, CO2 removal, apnea/bradycardia/desaturation events and work of breathing. The initial phase of the study is complete and preliminary analysis supports the hypothesis that there is no difference between the modalities when the mean airway pressure is equal. However we recognized that use of the RAM cannula, which does not transmit pressure effectively is an important study limitation. The findings are valid, but may only be applicable to this interface, which is widely used, but increasingly recognized as flawed. We are now extending the study to determine if the findings will be the same when short bi-nasal prongs are used.
Interventions
OTHERcontinuous positive airway pressure
Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Apnea/bradycardia events | Duration of intervention (12 hours) | Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean oxygen saturation by pulse oximetry and proportion of time below 88% | Duration of intervention (12 hours) | Mean oxygen saturation by pulse oximetry and proportion of time at saturation \<88% |
| Mean transcutaneous PCO2 and proportion of time >55 torr | Duration of intervention (12 hours) | Mean transcutaneous PCO2 and proportion of time at PCO2 \> 55 torr |
| Mean fraction of inspired oxygen | Duration of intervention (12 hours) | Mean fraction of inspired oxygen (FIO2) |
| Number of of desaturation events | Duration of intervention (12 hours) | Number of episodes of pulse oximetry readings that trigger alarm on the bedside monitor |
| Mean degrees of phase lag by RIP | Duration of intervention (12 hours) | Estimate of work of breathing based on phase angle as determined by respiratory inductive plethysmography |
| Number of episodes of feeding intolerance | Duration of intervention (12 hours) | number of instances of interruption of feeding, abdominal radiographs |
| Instances of treatment failure | Duration of intervention (12 hours) | Inability to tolerate assigned treatment by pre-defined criteria |
| Mean respiratory rate | Duration of intervention (12 hours) | Mean respiratory rate |
Countries
United States
Outcome results
None listed