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

University College Cork (UCC)

Status: Completed

Conditions: Very Low Birth Weight Infant; Extremely Low Birth Weight; Extreme Prematurity; Premature Birth

Treatments: Other: Held Position

Study type: Interventional

Funder types: Other

Identifiers

NCT05686252

21121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 28+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

30 degrees

Active Comparator group

Description:

Baby is held at 30 degrees during kangaroo mother care in the NICU

Treatment:

Other: Held Position

60 degrees

Active Comparator group

Description:

Baby is held at 60 degrees during kangaroo mother care in the NICU

Treatment:

Other: Held Position