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Simulated kangaroo care in very preterm infants does not reduce physiological instability: the COSYBABY randomised
Caroline Hartley1, Tricia Adjei1, Mohammad Chehrazi2
1Department of Paediatrics, University of Oxford, Oxford, United Kingdom.
Insights
The BABYBE mattress, designed to simulate kangaroo care, did not significantly reduce apnoeic episodes in preterm infants. This study highlights the under-documentation of apnoea in clinical notes compared to vital signs monitoring.
Area of Science:
- Neonatal Medicine
- Pediatric Critical Care
- Physiological Monitoring
Background:
- Very preterm infants often experience physiological instability, including apnoea, oxygen desaturation, and bradycardia, due to immature systems.
- Kangaroo care (parental skin-to-skin contact) may improve physiological stability, but continuous parental presence is not always feasible.
- The BABYBE SYSTEM® is a medical device developed to mimic kangaroo care for preterm infants.
Purpose of the Study:
- To evaluate the efficacy of the BABYBE mattress in reducing episodes of physiological instability, specifically apnoea, in very preterm infants.
- To compare the incidence of apnoeic episodes when the BABYBE mattress was active versus inactive.
Main Methods:
- A randomized cross-over trial involving 23 infants born before 32 weeks' gestation.
- Infants were monitored for five consecutive days, with alternating 12-hour periods of the BABYBE mattress being switched on or off.
- Physiological instability episodes were identified from vital signs monitor recordings and compared with clinical notes; generalized estimating equations were used for analysis.
Main Results:
- No statistically significant difference was found in the number of apnoeic episodes between the BABYBE mattress on and off conditions (p=0.09).
- A substantial discrepancy was observed between apnoeic episodes detected by vital signs recordings (1,157) and those documented in clinical notes (27).
- The trial included 23 infants born before 32 weeks' gestation.
Conclusions:
- The BABYBE mattress did not demonstrate a significant benefit in improving the physiological stability of preterm infants during the study period.
- The study confirms the significant under-recognition of apnoeic episodes in routine clinical documentation.
- Continuous assessment of electronic vital signs recordings is crucial for a comprehensive understanding of physiological stability in preterm neonates.
Introduction:
Infants who are born very preterm experience frequent episodes of physiological instability including apnoea, oxygen desaturation and bradycardia due to immaturity of the pulmonary and nervous systems. Parental contact, such as kangaroo care, may reduce physiological instability. However, there may be long periods when parents cannot be with their baby. The BABYBE SYSTEM® is a medical device designed to simulate kangaroo care.
Methods:
We conducted a randomised cross-over trial to determine whether episodes of apnoea and other episodes of physiological instability were reduced when infants were on an active BABYBE mattress. Each infant was included in the study for five consecutive days, with successive 12-h periods of the BABYBE® mattress being switched on or off. Episodes of physiological instability were identified from recordings of the vital signs monitors and compared with clinical notes. Generalised estimating equations models were used to compare physiological instability when the BABYBE mattress was switched on vs. off.
Results:
A total of 23 infants born before 32 weeks' gestation were included in the main analysis. There was no significant difference between the number of apnoeic episodes infants experienced in the 12-h period when the BABYBE mattress was on compared with when the mattress was switched off (difference between conditions = 1.5 apnoeas, 95% CI: -0.2-3.2, p = 0.09). The number of episodes of apnoea identified from vital signs recordings were much higher than those documented in the clinical records (a total of 1,157 apnoeic episodes were identified across all infants from vital signs recordings compared with a total of 27 documented in clinical/nursing notes of the same infants).
Discussion:
This trial does not provide evidence of a benefit of the BABYBE mattress for improving physiological stability in preterm infants. This study provides confirmation of the under-recognition of apnoeic episodes in clinical notes and the benefit of assessing electronic recordings of vital signs to gain a more complete picture of physiological stability.
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