Extreme PrematurityNCT05686252
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
A study testing Held Position in people with Extreme Prematurity and Extremely Low Birth Weight, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 weeks and older
- Conditions the study is for
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant
- What is being tested?
- Held Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 16 May 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Corrected gestational age under 28 weeks
- Known neurological anomalies (not intraventricular Haemorrhage)
- Known orthopaedic conditions
- Known chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants - A Randomised Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
- Being tested
- Held Position
- Keywords
- Kangaroo Mother Care, NIRS, Oxygen saturation, Heart rate, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Held PositionOther
Change in angle of held position during kangaroo mother care to alternative angle
| Study group | Role | What they receive |
|---|---|---|
| 30 degrees | Active comparator | Baby is held at 30 degrees during kangaroo mother care in the NICU Receives: Other: Held Position |
| 60 degrees | Active comparator | Baby is held at 60 degrees during kangaroo mother care in the NICU Receives: Other: Held Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cerebral NIRS values over KMC session
Mean cerebral NIRS values over the KMC session at the two different angles
Measured: 2 hours in total per infant
Secondary outcomes (4)
Mean peripheral saturation values over KMC session
Mean peripheral saturation values over the KMC session at the two different angles
Measured: 2 hours
Mean heart rate values over KMC session
Mean heart rate values over the KMC session at the two different angles
Measured: 2 hours
Number of bradycardias <100bpm over KMC session
Number of bradycardias <100bpm over the KMC session at the two different angles
Measured: 2 hours
Number of Desaturations less than 80% for > 20 secs over KMC session
Number of Desaturations less than 80% for > 20 secs over KMC session at the two different angles
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start16 May 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extreme PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Superiority Crossover Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Maternity Hospital
- Responsible party
- Principal investigator, Dr. Gene Dempsey, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686252
- Sponsor's protocol ID
- 21121
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16651294Charpak 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.
PubMed 27965377Jefferies 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.
PubMed 23449885Stapleton 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.
PubMed 40186001
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05686252
- Acronym / sponsor ID
- 21121
- Conditions
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
- Keywords
- Kangaroo Mother Care, NIRS, Oxygen saturation, Heart rate, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Cork University Maternity Hospital
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Superiority Crossover Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 30 degrees | Active comparator | Other: Held PositionBaby is held at 30 degrees during kangaroo mother care in the NICU |
| 60 degrees | Active comparator | Other: Held PositionBaby is held at 60 degrees during kangaroo mother care in the NICU |
Who may qualify
- Ages
- 28 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Corrected gestational age under 28 weeks
- Known neurological anomalies (not intraventricular Haemorrhage)
- Known orthopaedic conditions
- Known chromosomal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Held PositionChange in angle of held position during kangaroo mother care to alternative angle | Other | 30 degrees, 60 degrees |
Primary outcome
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
4 secondary outcomes
Mean peripheral saturation values over KMC session
Time frame: 2 hours
Mean heart rate values over KMC session
Time frame: 2 hours
Number of bradycardias <100bpm over KMC session
Time frame: 2 hours
Number of Desaturations less than 80% for > 20 secs over KMC session
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 16651294Ludington-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.
- Background: PubMed 27965377Charpak 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.
- Background: PubMed 23449885Jefferies 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.
- Derived from this study: PubMed 40186001Stapleton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Held Position in people with Extreme Prematurity and Extremely Low Birth Weight, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cerebral NIRS values over KMC session (time frame: 2 hours in total per infant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686252, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.