An interventional study of Held Position in Extreme Prematurity, Extremely Low Birth Weight and Very Low Birth Weight Infant, sponsored by University College Cork. Completed at 1 site in Ireland. Open to participants aged 28 Weeks and older. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by University College Cork · Not applicable, Interventional, and Supportive care
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.
In this proposed study the investigators will examine whether there is an optimal position in which to perform KMC. This will be performed by evaluating cerebral oxygenation with near infrared spectroscopy (NIRS). Cerebral Near-Infrared Spectroscopy (NIRS) is used as a non-invasive assessment of cerebral oxygenation and cerebral hemodynamics. NIRS gives an estimation of the regional cerebral tissue oxygenation via a probe attached to the baby's forehead. It is minimally invasive and won't interrupt any of baby's cares or interrupt time with parents. The investigators will use NIRS to specifically examine whether there is a difference in physiological parameters between being held when the Mother/Father is at a 30 degree or 60 degree angle on the bedside recliner and whether better oxygenation is associated with one position over another. Currently there are no studies assessing the optimal position to carry out KMC in neonatal units. This study proposes to help answer a question which has not yet been answered in the literature.
2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 20 is below the median of 84 across 1,688 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Baby is held at 30 degrees during kangaroo mother care in the NICU
Other: Held Position
Baby is held at 60 degrees during kangaroo mother care in the NICU
Other: Held Position
Change in angle of held position during kangaroo mother care to alternative angle
Mean cerebral NIRS values over KMC session
Mean cerebral NIRS values over the KMC session at the two different angles
Time frame: 2 hours in total per infant
Mean peripheral saturation values over KMC session
Mean peripheral saturation values over the KMC session at the two different angles
Time frame: 2 hours
Mean heart rate values over KMC session
Mean heart rate values over the KMC session at the two different angles
Time frame: 2 hours
Number of bradycardias <100bpm over KMC session
Number of bradycardias \<100bpm over the KMC session at the two different angles
Time frame: 2 hours
Number of Desaturations less than 80% for > 20 secs over KMC session
Number of Desaturations less than 80% for \> 20 secs over KMC session at the two different angles
Time frame: 2 hours
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University College Cork