NCT05686252

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 5, 2023

Last Update Submit

January 16, 2023

Conditions

Extreme PrematurityExtremely Low Birth WeightVery Low Birth Weight InfantPremature Birth

Keywords

Kangaroo Mother CareNIRSOxygen saturationHeart rateNICU

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Mean peripheral saturation values over KMC session

    2 hours

  • Mean heart rate values over KMC session

    2 hours

  • Number of bradycardias <100bpm over KMC session

    2 hours

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

    2 hours

Study Arms (2)

30 degrees

ACTIVE COMPARATOR

Baby is held at 30 degrees during kangaroo mother care in the NICU

Other: Held Position

60 degrees

ACTIVE COMPARATOR

Baby is held at 60 degrees during kangaroo mother care in the NICU

Other: Held Position

Interventions

Held PositionOTHER

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

30 degrees60 degrees

Eligibility Criteria

Age28 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Corrected gestational age under 28 weeks
  • Known neurological anomalies (not intraventricular Haemorrhage)
  • Known orthopaedic conditions
  • Known chromosomal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Maternity Hospital, Wilton

Cork, Munster, Ireland

Location

Related Publications (4)

  • Ludington-Hoe SM, Johnson MW, Morgan K, Lewis T, Gutman J, Wilson PD, Scher MS. Neurophysiologic assessment of neonatal sleep organization: preliminary results of a randomized, controlled trial of skin contact with preterm infants. Pediatrics. 2006 May;117(5):e909-23. doi: 10.1542/peds.2004-1422.

    PMID: 16651294BACKGROUND

  • Charpak N, Tessier R, Ruiz JG, Hernandez JT, Uriza F, Villegas J, Nadeau L, Mercier C, Maheu F, Marin J, Cortes D, Gallego JM, Maldonado D. Twenty-year Follow-up of Kangaroo Mother Care Versus Traditional Care. Pediatrics. 2017 Jan;139(1):e20162063. doi: 10.1542/peds.2016-2063. Epub 2016 Dec 12.

    PMID: 27965377BACKGROUND

  • Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee. Kangaroo care for the preterm infant and family. Paediatr Child Health. 2012 Mar;17(3):141-6. doi: 10.1093/pch/17.3.141.

    PMID: 23449885BACKGROUND

  • Stapleton I, Murphy S, Vaughan S, Walsh BH, Natchimuthu K, Livingstone V, Dempsey E. The effect of maternal position on cerebral oxygenation in premature infants during Kangaroo care: a randomised controlled trial. J Perinatol. 2025 Nov;45(11):1552-1557. doi: 10.1038/s41372-025-02287-0. Epub 2025 Apr 5.

    PMID: 40186001DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Superiority Crossover Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 17, 2023

Study Start

May 16, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

IE(1)