Kangaroo CareCangulatNCT03990116
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.
A study testing Lateral and Prone in people with Kangaroo Care and Premature Infant, run by Laura Collados Gomez at 1 site in Spain.
Trial summary
The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life. Read more about this study
- Who is it for?
- Ages 1 minute to 5 days
- Conditions the study is for
- Kangaroo Care, Premature Infant, Body Temperature
- What is being tested?
- Lateral and Prone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2019to 15 Nov 2021
- 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 1 minute to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature under 28 weeks of gestational age with mother / father who wants kangaroo care.
Who cannot join
- Premature infants with mechanical ventilation in high frequency mode,
- Premature infants in the immediate postoperative period of major surgery,
- Premature infants with malformations of the abdominal Wall
- Premature infants who require immobilization
- Premature infants who do not tolerate kangaroo care: hemodynamic, thermal instability or increased stress
- Premature infants with duration of kangaroo care of less than 60 minutes.
- Also excluded are those patients where the kangaroo care provider has an anatomical limitation for carrying out kangaroo care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant
The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.
Read the detailed description
A non-inferiority clinical trial, controlled, randomized and not blinded has been designed. The non-equivalent, experimental group consist on neonates less than 28 weeks of gestational age who are placed in lateral position while they are on kangaroo care during the first 5 days of life. On the other hand, the control group include neonates less than 28 weeks of gestational age who are in traditional prone position during kangaroo care on the first 5 days of life.
To define the sample size a power of 80% is assumed (β=0,20) and a 95% confidence interval (α=0,05) with a difference of 0,3ºC (SD 0,16) (9,10) in the axillary temperature. A non inferiority margin of 0.2ºC is established and a 10% sample size loss has been assumed. So a sample size of 35 premature in each group has been estimated.
A non probabilistic and consecutive sampling has been defined. The allocation into the experimental (lateral position) or control group (prone position) is going to be randomized.
The main outcome variable is the axillary temperature. However other clinical variables as pain, changes in the vital signs, HIV incidence rate are going to be measured as well.
- Conditions
- Kangaroo Care, Premature Infant, Body Temperature
- Being tested
- Lateral, Prone
- Keywords
- Patient Positioning, Kangaroo-Mother Care Method, skin to skin, Extremely Premature infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LateralProcedure or surgery
Posture lateral kangaroo care
ProneProcedure or surgery
Posture prone kangaroo care
| Study group | Role | What they receive |
|---|---|---|
| Lateral kangaroo | Experimental | Placing the infant in lateral on the parents chest, keeping the head neutral and limbs flexed towards body midline Receives: Procedure: Lateral |
| Prone Kangaroo | Active comparator | placing the baby in upright and ventral position between mother's breasts or over the father chest, in skin-to skin contact with no clothes in between and with lower limbs flexed Receives: Procedure: Prone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from skin temperature
Change from skin temperature after kangaroo care Peripheral temperature of the premature measured in the axilla with Braun® PRT2000 thermometer and the continuous temperature monitoring sensor of Giraffe ® incubators (AirLife TM infant skin temperature probe)
Measured: T0: baseline; T1: 30 minutes after to start kangaroo care; T2: 30 minutes after to finish kangaroo care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start10 May 2019
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kangaroo CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Collados Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Collados Gomez, Hospital Universitario 12 de Octubre
- Investigators
- Laura Collados, phD, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990116
- Sponsor's protocol ID
- NEO_nur_19
- Acronym
- Cangulat
- Status last verified
- Sep 2025
- First submitted
- 23 May 2019
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collados-Gomez L, Solaz-Garcia A, Jimenez-Fernandez L, Piris-Borregas S, Lopez-Maestro M. Thermal Stability of Extremely Preterm Infants During Early Kangaroo Mother Care in the First 5 Days of Life. Adv Neonatal Care. 2026 Jul 15. doi: 10.1097/ANC.0000000000001388. Online ahead of print.
PubMed 42462083Collados-Gomez L, Esteban-Gonzalo L, Lopez-Lopez C, Jimenez-Fernandez L, Piris-Borregas S, Garcia-Garcia E, Fernandez-Gonzalo JC, Martinez-Miguel E. Lateral Kangaroo Care in Hemodynamic Stability of Extremely Preterm Infants: Protocol Study for a Non-Inferiority Randomized Controlled Trial CANGULAT. Int J Environ Res Public Health. 2021 Dec 28;19(1):293. doi: 10.3390/ijerph19010293.
PubMed 35010554
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant
- ClinicalTrials.gov ID
- NCT03990116
- Acronym / sponsor ID
- Cangulat / NEO_nur_19
- Conditions
- Kangaroo Care, Premature Infant, Body Temperature
- Keywords
- Patient Positioning, Kangaroo-Mother Care Method, skin to skin, Extremely Premature infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Laura Collados GomezUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 18 Jun 2019 (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 objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.
Detailed description
A non-inferiority clinical trial, controlled, randomized and not blinded has been designed. The non-equivalent, experimental group consist on neonates less than 28 weeks of gestational age who are placed in lateral position while they are on kangaroo care during the first 5 days of life. On the other hand, the control group include neonates less than 28 weeks of gestational age who are in traditional prone position during kangaroo care on the first 5 days of life.
To define the sample size a power of 80% is assumed (β=0,20) and a 95% confidence interval (α=0,05) with a difference of 0,3ºC (SD 0,16) (9,10) in the axillary temperature. A non inferiority margin of 0.2ºC is established and a 10% sample size loss has been assumed. So a sample size of 35 premature in each group has been estimated.
A non probabilistic and consecutive sampling has been defined. The allocation into the experimental (lateral position) or control group (prone position) is going to be randomized.
The main outcome variable is the axillary temperature. However other clinical variables as pain, changes in the vital signs, HIV incidence rate are going to be measured as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral kangaroo | Experimental | Procedure: LateralPlacing the infant in lateral on the parents chest, keeping the head neutral and limbs flexed towards body midline |
| Prone Kangaroo | Active comparator | Procedure: Proneplacing the baby in upright and ventral position between mother's breasts or over the father chest, in skin-to skin contact with no clothes in between and with lower limbs flexed |
Who may qualify
- Ages
- 1 minute to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature under 28 weeks of gestational age with mother / father who wants kangaroo care.
Key exclusion criteria (7 listed)
- Premature infants with mechanical ventilation in high frequency mode,
- Premature infants in the immediate postoperative period of major surgery,
- Premature infants with malformations of the abdominal Wall
- Premature infants who require immobilization
- Premature infants who do not tolerate kangaroo care: hemodynamic, thermal instability or increased stress
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 |
|---|---|---|
| LateralPosture lateral kangaroo care | Procedure or surgery | Lateral kangaroo |
| PronePosture prone kangaroo care | Procedure or surgery | Prone Kangaroo |
Primary outcome
Change from skin temperature
Time frame: T0: baseline; T1: 30 minutes after to start kangaroo care; T2: 30 minutes after to finish kangaroo care
Change from skin temperature after kangaroo care Peripheral temperature of the premature measured in the axilla with Braun® PRT2000 thermometer and the continuous temperature monitoring sensor of Giraffe ® incubators (AirLife TM infant skin temperature probe)
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 26 Sep 2025.
- Derived from this study: PubMed 42462083Collados-Gomez L, Solaz-Garcia A, Jimenez-Fernandez L, Piris-Borregas S, Lopez-Maestro M. Thermal Stability of Extremely Preterm Infants During Early Kangaroo Mother Care in the First 5 Days of Life. Adv Neonatal Care. 2026 Jul 15. doi: 10.1097/ANC.0000000000001388. Online ahead of print.
- Derived from this study: PubMed 35010554Collados-Gomez L, Esteban-Gonzalo L, Lopez-Lopez C, Jimenez-Fernandez L, Piris-Borregas S, Garcia-Garcia E, Fernandez-Gonzalo JC, Martinez-Miguel E. Lateral Kangaroo Care in Hemodynamic Stability of Extremely Preterm Infants: Protocol Study for a Non-Inferiority Randomized Controlled Trial CANGULAT. Int J Environ Res Public Health. 2021 Dec 28;19(1):293. doi: 10.3390/ijerph19010293.
- Individual participant dataSharing planned: No
Related trials for Kangaroo Care
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
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The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
Procedural Pain, Neonatal Hyperbilirubinemia
Not yet recruiting
The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation
Newborn Care
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
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.
Laura Collados, phD principal investigator
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral and Prone in people with Kangaroo Care and Premature Infant, run by Laura Collados Gomez at 1 site in Spain.
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 1 inclusion and 7 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 26 Sep 2025. 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 Spain. 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?
Change from skin temperature (time frame: T0: baseline; T1: 30 minutes after to start kangaroo care; T2: 30 minutes after to finish kangaroo care). 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 NCT03990116, which also lists 2 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 26 Sep 2025.