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Completed
NCT05686252
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
Conditions: Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
Sex: All
Ages: 28 Weeks – N/A
Phase: NA
Enrollment: 20
Sponsor: University College Cork
Location: Ireland
Summary
The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU.
The main question it aims to answer is: 1) is there an optimal position for an infant to be held during KMC and 2) to optimise benefits for infants receiving KMC.
Participants will be: 1) randomised into two groups which determine which angle they will start at first, 2) assessed over two hour-long sessions on different days with a change in the angle at the 30 minute point, 3) monitored using a Massimo NIRS machine which will record oxygen saturations, cerebral NIRS values and heart rates, and 4) monitored for any episodes of desaturations and bradycardias during this time.
Participants will then be assessed beginning with the the other angle first on a different day.
The researchers will then compare the two groups to see if being held at a 30 degrees during KMC is superior to being held at 60 degrees in terms of physiological stability.
Eligibility Criteria
Inclusion Criteria:Ex-premature infants who are a minimum of 28 weeks corrected gestational ageMinimum weight at assessment for entry to study 600gSigned informed consent formExclusion Criteria:Corrected gestational age under 28 weeksKnown neurological anomalies (not intraventricular Haemorrhage)Known orthopaedic conditionsKnown chromosomal anomalies
Source: ClinicalTrials.gov (NCT05686252). StuddyBuddy aggregates publicly available trial information.