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NCT05686252

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

Completed NA Last updated 19 January 2023
What this trial tests

NA trial testing Held Position in Extreme Prematurity in 20 participants. Completed in 30 September 2022.

Timeline
16 May 2022
Primary endpoint
30 September 2022
30 September 2022

Quick facts

Lead sponsorUniversity College Cork
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposesupportive care
Enrollment20
Start date16 May 2022
Primary completion30 September 2022
Estimated completion30 September 2022
Sites1 location across Ireland

Drugs / interventions tested

Conditions studied

Sponsor

University College Cork

Who can join

28 Weeks and older, any sex, with Extreme Prematurity or Extremely Low Birth Weight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effect of maternal position on cerebral oxygenation in premature infants during Kangaroo care: a randomised controlled trial.
    Stapleton I, Murphy S, Vaughan S, Walsh BH, et al · · 2025 · PMID 40186001 · DOI 10.1038/s41372-025-02287-0
  2. The Effect of Maternal Position on Cerebral Oxygenation in Premature Infants During Kangaroo Care: a Randomised Controlled Trial
    Stapleton I, Murphy S, Vaughan S, Walsh B, et al · · 2024 · DOI 10.21203/rs.3.rs-5363349/v1

Verify or expand the search:

Other recruiting trials for Extreme Prematurity

Currently open trials in the same condition.

Other University College Cork trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05686252.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing