CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Held Positionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05686252
NCT05686252N/ACompleted

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

University College Cork·interventional·Posted Jan 17, 2023·Updated Jan 19, 2023

In Brief

A clinical study evaluating Held Position for Extreme Prematurity and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 17, 2023
Enrollment StartMay 16, 2022
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.5 years ago

Interventions

Held Positionother

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