An interventional study of 20 per minute stimulus and 30 per minute stimulus in Apnea of Prematurity and Intermittent Hypoxia, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to compare, in healthy preterm babies, 9 doses of dorsal mechanical stimuli, in order to answer:
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.
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 infant's 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 and/or detect relevant respiratory patterns that improve minute ventilation.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: 24-34 weeks of birth gestational age (BGA) preterms, healthy -
Exclusion Criteria: respiratory support, thoracic or abdominal malformations-recent surgeries, hypotonic syndromes
-
Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 3 mm , performed by 2 operators .
Device: 20 per minute stimulus · Device: 30 per minute stimulus · Device: 40 per minute stimulus
Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 5 mm , performed by 2 operators .
Device: 20 per minute stimulus · Device: 30 per minute stimulus · Device: 40 per minute stimulus
Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 8 mm , performed by 2 operators .
Device: 20 per minute stimulus · Device: 30 per minute stimulus · Device: 40 per minute stimulus
Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm basal- without stimulation- performed by 2 operators .
crossover randomized mechanical dorsal stimuli -for one minute each- at 20-rates per minute
crossover randomized mechanical dorsal stimuli -for one minute each- at 30 rates per minute
crossover randomized mechanical dorsal stimuli -for one minute each- at 40 rates per minute
Comparison of mean of Tidal Volume(TV) between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean of Tidal Volume ( ml/kg)
Time frame: 1 minute for each intervention ( dose)
Comparison of mean of Minute Ventilation (MV) between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean of MV ( ml/kg/ min)
Time frame: 1 minute for each intervention ( dose)
Comparison of mean of Respiratory Rate (RR)between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean RR (rpm)
Time frame: 1 minute for each intervention ( dose)
Comparison of mean of Cardiac Rate (CR)between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean CR (rpm)
Time frame: 1 minute for each intervention ( dose)
Comparison of mean of percent of oxygen saturation (Sats) between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean Sats (percent)
Time frame: 1 minute for each intervention ( dose)
Analyss of pattern of respiratory drive between the doses of dorsal mechanical stimuli
Qualitative description of the respiratory drive( synchronicity-asynchronicity)
Time frame: 1 minute for each intervention ( dose)
Risk manangement
Description of Adverse Events( Neonatal Infant Pain Score (NIPS) \>2-skin reactions-Apnea- Desaturation)
Time frame: 45-60 minutes each patient
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pontificia Universidad Catolica de Chile