Apnea of Newborn, Preterm Labor
Conditions
Keywords
respiratory rate, scare ventilator, sleep wake cycle
Brief summary
Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator"
Detailed description
With this pilot study the investigator's want to see if the "scare respirator" can modify the vital signs of the newborn (NB) and if there is a relationship according to the frequency per minute given by the scare respirator and the patient's respiratory rate. The "scare respirator" has been used many times to prevent central apnea in the newborn. This involves using a mechanical ventilator, but instead of connecting it to the patient's trachea to inflate his lungs, the air flow is connected to a surgical glove that inflates and deflates, with the optimal respiratory rate that the patient should have. This will be placed on the back to stimulate it tactically giving the necessary impulse of inspiration so that the patient alone can acquire the movement. The importance of the development of this study is that it has been seen that the "scare respirator" could avoid central apneas, but no studies have been done on the change in respiratory rate that occurs with the device or if it bothers the NB or alters its wakefulness sleep pattern. It is intended to evaluate 10 premature infants, during 3 observation periods. Heart rate (HR), Respiratory rate (RR) and saturation, pain scale and aEEG sleep wake pattern will be evaluated; first a rest period between feeds as baseline, then with a scare respirator at 20 cycles per minute and finally at 40 cycles per minute. The differences of qualitative and quantitative variables will be assessed with ad-hoc statistical tests.
Interventions
DEVICEwithout any device
Basal analysis
DEVICEscare ventilator at 20
To set scare ventilator by 20 cycles per minute
DEVICEscare ventilator at 40
To set scare ventilator by 40 cycles per minute
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The order of intervention was not masked, but the results were masked before the primary analisys
Intervention model description
10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- hospitalized healthy preterm babies,
Exclusion criteria
* babies receiving mechanical ventilation * carrier of any mayor malformation or genetic condition * sick or having an thorax or abdomen surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm) | 2 hours interfedings at the study day | % of time were respiratory rate is synchronised with the scare ventilator input, two tales of statistical differences, at 20 and 40 cycles per minute (cpm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on oxygen saturation using the scare ventilator at 20 cpm | 2 hours interfedings at the study day | differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods |
| Change from baseline on oxygen saturation using the scare ventilator at 40 cpm | 2 hours interfedings at the study day | differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods |
| Adverse events | From enrollment to the end of the hospitalization time | Register and look active for adverse events during interventions |
| Change from baseline newborn HR using the scare ventilator at 20 cpm | 2 hours interfedings at the study day | differences in HR mean with two tales of statistical analysis ,between the two study periods |
| Change from baseline newborn HR using the scare ventilator at 40 cpm | 2 hours interfedings at the study day | differences in HR mean with two tales of statistical analysis ,between the two study periods |
| Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm | 2 hours interfedings at the study day | % of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods |
| Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm | 2 hours interfedings at the study day | % of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods |
| Change from baseline on Discomfort scale using the scare ventilator at 20 cpm | 2 hours interfedings at the study day | Differences with the NIPS average, two tales of statistical differences, between the two study periods (scale 0-10; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain) |
| Change from baseline on Discomfort scale using the scare ventilator at 40 cpm | 2 hours interfedings at the study day | Differences with the NIPS average, two tales of statistical differences, between the two study periods (scale 0-10; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain) |
| Change from baseline on RR using the scare ventilator at 40 cpm | 2 hours interfedings at the study day | differences in RR mean with two tales of statistical differences between the two periods |
| Change from baseline on RR using the scare ventilator at 20 cpm | 2 hours interfedings at the study day | differences in RR mean with two tales of statistical differences between the two periods |
Countries
Chile
Contacts
PRINCIPAL_INVESTIGATORPaulina Toso, MD
Pontificia Universidad Catolica de Chile
Outcome results
None listed