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Completed

NCT Number: NCT05686252

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

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.

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Key information

Conditions

Extreme Prematurity Extremely Low Birth Weight Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Very Low Birth Weight Infant

Age range

28 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cork University Maternity Hospital, Wilton

Cork, Munster, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Held Position

Other

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

Primary outcomes

  1. Mean cerebral NIRS values over KMC session

    Time frame: 2 hours in total per infant

    Mean cerebral NIRS values over the KMC session at the two different angles

Secondary outcomes

  1. Mean peripheral saturation values over KMC session

    Time frame: 2 hours

    Mean peripheral saturation values over the KMC session at the two different angles

  2. Mean heart rate values over KMC session

    Time frame: 2 hours

    Mean heart rate values over the KMC session at the two different angles

  3. Number of bradycardias <100bpm over KMC session

    Time frame: 2 hours

    Number of bradycardias <100bpm over the KMC session at the two different angles

  4. Number of Desaturations less than 80% for > 20 secs over KMC session

    Time frame: 2 hours

    Number of Desaturations less than 80% for > 20 secs over KMC session at the two different angles

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Cork University Maternity Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2023
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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