CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Women's Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/16/2018 |
| Start Date: | September 30, 2017 |
| End Date: | June 2019 |
| Contact: | Martin Keszler, MD |
| Email: | mkeszler@wihri.org |
| Phone: | 401 274 1122 |
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 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.
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.
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.
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.
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
We found this trial at
1
site
101 Dudley St
Providence, Rhode Island 02905
Providence, Rhode Island 02905
(401) 274-1100
Phone: 401-274-1122
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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