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

Sponsor

University College Cork (Other)

Overall Status

Completed

CT.gov ID

NCT05686252

Collaborator

Cork University Maternity Hospital (Other)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extreme Prematurity Extremely Low Birth Weight Very Low Birth Weight Infant Premature Birth	Other: Held Position	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Superiority Crossover Randomised Controlled TrialSuperiority Crossover Randomised Controlled Trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 16, 2022

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 30 degrees Baby is held at 30 degrees during kangaroo mother care in the NICU	Other: Held Position Change in angle of held position during kangaroo mother care to alternative angle
Active Comparator: 60 degrees 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

Arm

Intervention/Treatment

Active Comparator: 30 degrees

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

Other: Held Position

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

Active Comparator: 60 degrees

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

Outcome Measures

Primary Outcome Measures

Mean cerebral NIRS values over KMC session [2 hours in total per infant]
Mean cerebral NIRS values over the KMC session at the two different angles

Secondary Outcome Measures

Mean peripheral saturation values over KMC session [2 hours]
Mean peripheral saturation values over the KMC session at the two different angles
Mean heart rate values over KMC session [2 hours]
Mean heart rate values over the KMC session at the two different angles
Number of bradycardias <100bpm over KMC session [2 hours]
Number of bradycardias <100bpm over the KMC session at the two different angles
Number of Desaturations less than 80% for > 20 secs over KMC session [2 hours]
Number of Desaturations less than 80% for > 20 secs over KMC session at the two different angles