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RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants

Investigating the Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants - A Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05686252
Enrollment
20
Registered
2023-01-17
Start date
2022-05-16
Completion date
2022-09-30
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremely Low Birth Weight, Extreme Prematurity, Premature Birth, Very Low Birth Weight Infant

Keywords

Kangaroo Mother Care, NIRS, Oxygen saturation, Heart rate, NICU

Brief 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.

Detailed description

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.

Interventions

OTHERHeld Position

Change in angle of held position during kangaroo mother care to alternative angle

Sponsors

Cork University Maternity Hospital
CollaboratorOTHER
University College Cork
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Superiority Crossover Randomised Controlled Trial

Eligibility

Sex/Gender
ALL
Age
28 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

* Ex-premature infants who are a minimum of 28 weeks corrected gestational age * Minimum weight at assessment for entry to study 600g * Signed informed consent form

Exclusion criteria

* Corrected gestational age under 28 weeks * Known neurological anomalies (not intraventricular Haemorrhage) * Known orthopaedic conditions * Known chromosomal anomalies

Design outcomes

Primary

MeasureTime frameDescription
Mean cerebral NIRS values over KMC session2 hours in total per infantMean cerebral NIRS values over the KMC session at the two different angles

Secondary

MeasureTime frameDescription
Mean peripheral saturation values over KMC session2 hoursMean peripheral saturation values over the KMC session at the two different angles
Mean heart rate values over KMC session2 hoursMean heart rate values over the KMC session at the two different angles
Number of bradycardias <100bpm over KMC session2 hoursNumber of bradycardias \<100bpm over the KMC session at the two different angles
Number of Desaturations less than 80% for > 20 secs over KMC session2 hoursNumber of Desaturations less than 80% for \> 20 secs over KMC session at the two different angles

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026