Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639581
Status:
COMPLETED
Last Update Posted:
None
First Post:
2022-09-29
Brief Title:
Pilot Study to Evaluate Doses of Mechanical Stimulus on the Effectiveness of Preterm Breathing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of 9 Doses of Dorsal Mechanical Stimulus on Volume Respiratory Measures on Healthy Preterms a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare in healthy preterm babies 9 doses of dorsal mechanical stimuli in order to answer
if there is a dose of dorsal mechanical stimuli that improves the basal respiration
Participants will be stimulated through a cotton shirt for one minute with each dose while respiratory measures will be taken through a nasobuccal mask slightly tightened by the investigator staff All time babies are going to be monitored and assessing that they are comfortable
if there is a dose of dorsal mechanical stimuli that improves the basal respiration
Participants will be stimulated through a cotton shirt for one minute with each dose while respiratory measures will be taken through a nasobuccal mask slightly tightened by the investigator staff All time babies are going to be monitored and assessing that they are comfortable
Detailed Description:
Apnea of Prematurity AOP occurs in 90 of infants born at 34 weeks of gestation Despite current treatments these infants continue to experience intermittent hypoxia IH events which lead to subsequent complications Dorsal and extremity kinesthetic stimulation-commonly practiced in patients experiencing apnea-has been shown to trigger the infants own respiratory effort Several clinical studies have demonstrated that mechanized or reactive stimulation performed with various devices and at different intensities decreases the number of apneas and reduces the time spent with oxygen saturation levels below 90 a measure of IH However there are also reports of no favorable effects with certain other stimulation mechanisms
To study the kinesthetic mechanism a pilot study was conducted on 10 healthy premature infants The infants were dorsally stimulated using a surgical glove inflated by a mechanical ventilator at rates of 20 and 40 cycles per minute applying a standardized stimulus independent of weight and gestational age The main results showed that during the stimulation period the respiratory rate decreased by 19-50 compared to baseline without stimulation while oxygen saturation increased by 2-7 percentage points Additionally it was observed that synchronization of breathing with the dorsal stimulus occurred 0-77 of the time
These observations could be explained by the assumption that premature infants achieved more effective breaths through stimulation recruiting more alveolar units and potentially triggering the Hering-Breuer reflex which inhibits subsequent respiratory efforts Although these findings were statistically significant based on the analysis of paired sample means not all infants responded in the same way
Method A pilot study involving 10 healthy preterm infants 24-34 weeks gestational age will be conducted The infants will be stimulated on their backs with different combinations of lifting 3 5 and 8 mm and frequency 20 30 and 40 cycles per minute using a shirt equipped with an inflating-deflating actuator The main outcome will be a comparison of minute ventilation and tidal volumes at baseline and with the different stimulation doses The software Rec Trial will be used to record vital signs operational settings respiratory volumes and patterns for repeated measures ANOVA analysis The expected results are to find the optimal combination of lifting and frequency stimulus to optimize minute ventilation andor detect relevant respiratory patterns that improve minute ventilation
To study the kinesthetic mechanism a pilot study was conducted on 10 healthy premature infants The infants were dorsally stimulated using a surgical glove inflated by a mechanical ventilator at rates of 20 and 40 cycles per minute applying a standardized stimulus independent of weight and gestational age The main results showed that during the stimulation period the respiratory rate decreased by 19-50 compared to baseline without stimulation while oxygen saturation increased by 2-7 percentage points Additionally it was observed that synchronization of breathing with the dorsal stimulus occurred 0-77 of the time
These observations could be explained by the assumption that premature infants achieved more effective breaths through stimulation recruiting more alveolar units and potentially triggering the Hering-Breuer reflex which inhibits subsequent respiratory efforts Although these findings were statistically significant based on the analysis of paired sample means not all infants responded in the same way
Method A pilot study involving 10 healthy preterm infants 24-34 weeks gestational age will be conducted The infants will be stimulated on their backs with different combinations of lifting 3 5 and 8 mm and frequency 20 30 and 40 cycles per minute using a shirt equipped with an inflating-deflating actuator The main outcome will be a comparison of minute ventilation and tidal volumes at baseline and with the different stimulation doses The software Rec Trial will be used to record vital signs operational settings respiratory volumes and patterns for repeated measures ANOVA analysis The expected results are to find the optimal combination of lifting and frequency stimulus to optimize minute ventilation andor detect relevant respiratory patterns that improve minute ventilation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None