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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Held Position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Superiority Crossover Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30 degrees<br>Baby is held at 30 degrees during kangaroo mother care in the NICU | Other: Held Position<br>* Change in angle of held position during kangaroo mother care to alternative angle<br>|
| Active Comparator: 60 degrees<br>Baby is held at 60 degrees during kangaroo mother care in the NICU | Other: Held Position<br>* Change in angle of held position during kangaroo mother care to alternative angle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cerebral NIRS values over KMC session | Mean cerebral NIRS values over the KMC session at the two different angles | 2 hours in total per infant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean peripheral saturation values over KMC session | Mean peripheral saturation values over the KMC session at the two different angles | 2 hours | 
| Mean heart rate values over KMC session | Mean heart rate values over the KMC session at the two different angles | 2 hours | 
| Number of bradycardias <100bpm over KMC session | Number of bradycardias <100bpm over the KMC session at the two different angles | 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 | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kangaroo Mother Care, NIRS, Oxygen saturation, Heart rate, NICU