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

NCT05686252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-19

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Held Position

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

Sponsors & Collaborators

  • Cork University Maternity Hospital

    collaborator OTHER

  • University College Cork

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05686252 on ClinicalTrials.gov