Preterm BirthKangarooNCT04865302
Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth
An observational study of Preterm Birth and Ventilator Lung; Newborn, run by Medical University of Graz at 1 site in Austria.
Trial summary
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth. Read more about this study
- Who is it for?
- Ages 15 minutes to 24 hours
- Conditions the study is for
- Preterm Birth, Ventilator Lung; Newborn
- What is being tested?
- SSC
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2021to 11 Apr 2024
- Phase
- Observational
- 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 15 minutes to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates <37+0 weeks of gestation admitted to the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section will be eligible for the study.
Who may be able to join
- Need for respiratory support (endotracheal tube [ETT], nasal continuous positive airway pressure [nCPAP], high-flow nasal cannula [HFNC])
- Decision to conduct full life support
- Written informed consent
Who cannot join
- No decision to conduct full life support
- No written informed consent
- Severe congenital malformations, severe asphyxia (umbilical cord artery pH <7.00)
- Cerebral malformations, posthaemorrhagic ventricular dilatation, intraventricular haemorrhage grade III, periventricular haemorrhage
- Cardiovascular instability (need for catecholamines)
- No need for respiratory support
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, 8036
About this study
Official title: Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth - a Prospective Observational Pilot Study
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth.
Read the detailed description
Background
Kangaroo mother care (KMC) or skin-to-skin care (SSC) is a routine method of care in preterm neonates in neonatal intensive care units around the world. SSC is mostly defined as the skin-to-skin contact of the infant with the mother's or father's chest, which has been proven to reduce mortality, decrease severe illness, nosocomial infections and the length of hospital stay as well as to improve growth, breastfeeding and mother-child-relationship. During the last years several studies were performed showing that SSC provides comparable neonatal physiological stability compared to routine incubator care.
Near-infrared spectroscopy (NIRS) enables non-invasive, continuous monitoring of oxygenation and perfusion in different tissues. Several studies have shown that SSC has no negative influence on cerebral oxygenation saturation and physiological parameters compared to routine incubator care in preterm infants with respiratory support after the 5th day after birth. Nevertheless, until now there is no information on cerebral oxygenation and physiological parameters during SSC compared to routine incubator care in preterm neonates with respiratory support during the first 24 hours after birth, when transition still takes place and may cause unstable vital signs in neonates. Cerebral hypoxia as well as hyperoxia can cause severe brain damage due to perfusion disturbances, especially in ventilated preterm neonates.
Objectives
Primary aim: To assess, if the burden of cerebral hypoxia (calculated as the area under the curve outside the tissue oxygenation (cStO2) target range of 55% - 76%) in preterm neonates with respiratory support is different during SSC compared to routine incubator care on the first day after birth.
Secondary aims: To assess, if SSC has an influence on cFTOE (cerebral fractional tissue oxygen extraction) and routine monitoring parameters (arterial oxygen saturation [SpO2], heart rate [HR], respiratory rate [RR], mean arterial blood pressure [MABP], temperature) in preterm neonates with respiratory support compared to routine incubator care on the first day after birth.
Methods
Study population: Preterm neonates <37+0 weeks of gestation with respiratory support admitted to the Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section will be eligible for the study.
Procedure: Patients and maternal medical history and main diagnoses, as well as routinely sampled laboratory results, provided therapy and respiratory support will be documented in each neonate.´
Measurements: For NIRS measurements the OxyPrem 1.4. (OxyPrem AG, Zurich, Switzerland) will be used. The NIRS measurements will take place once during the first day after birth before / during / after routine SSC and will last for 180 minutes.
After feeding the neonates will be brought in a prone position in the incubator and the NIRS sensor will be applied on the forehead for continuous cStO2 measurements throughout the study period. The neonate will rest in this position for 60 minutes. Afterwards the neonate will be brought on the mother's or father's chest (skin to skin) in a prone position and will stay in this position for 60 minutes. Finally the neonates will be brought back into the incubator for another 60 minutes in prone position. After 180 minutes the study period is over and the NIRS sensor will be removed.
Furthermore, NIRS will be combined with routine monitoring, such as pulse oxymetry (SpO2, HR), blood pressure measurements and measurements of temperature. Data will be stored in a polygraphic system (alpha-trace digitalMM, B.E.S.T. Medical Systems, Austria) for further analysis.
- Conditions
- Preterm Birth, Ventilator Lung; Newborn
- Being tested
- SSC
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSCProcedure or surgery
Incubator phase I: After feeding the neonates will be brought in a prone position in the incubator and the NIRS sensor will be applied on the forehead for continuous cStO2 measurements throughout the study period. The neonate will rest in this position for 60 minutes.
SSC phase: The neonate will be brought on the mother's or father's chest (skin to skin) in a prone position and will stay in this position for 60 minutes.
Incubator phase II: The neonates will be brought back into the incubator for another 60 minutes in prone position. After 180 minutes the study period is over and the NIRS sensor will be removed.
What is being measured
The primary outcome is the main question the study is designed to answer.
percent minutes of cerebral hypoxia
After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase I" over 40 minutes.
Measured: 60 minutes
percent minutes of cerebral hypoxia
After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "SSC" over 40 minutes.
Measured: 60 minutes
percent minutes of cerebral hypoxia
After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase II" over 40 minutes.
Measured: 60 minutes
Secondary outcomes (21)
Mean StO2
Mean StO2 values over 40 minutes, calculated for intervention period "incubator phase I", after washout time will be calculated
Measured: 60 minutes
Mean StO2
Mean StO2 values over 40 minutes, calculated for intervention period "SSC", after washout time will be calculated
Measured: 60 minutes
Mean StO2
Mean StO2 values over 40 minutes, calculated for intervention period "incubator phase II" after washout time will be calculated
Measured: 60 minutes
Mean cFTOE
Mean cFTOE values over 40 minutes for intervention period "incubator phase I" after washout time will be calculated
Measured: 60 minutes
Mean cFTOE
Mean cFTOE values over 40 minutes for intervention period "SSC" after washout time will be calculated
Measured: 60 minutes
Mean cFTOE
Mean cFTOE values over 40 minutes for intervention period "incubator phase II" after washout time will be calculated
Measured: 60 minutes
Mean routine monitoring parameters :SpO2
SpO2 for intervention period "incubator phase I"
Measured: 60 minutes
Mean routine monitoring parameters :SpO2
SpO2 for intervention period "SSC"
Measured: 60 minutes
Mean routine monitoring parameters :SpO2
SpO2 for intervention period "incubator phase II"
Measured: 60 minutes
Mean routine monitoring parameters: HR
HR for intervention period "incubator phase I"
Measured: 60 minutes
Mean routine monitoring parameters: HR
HR for intervention period "SSC"
Measured: 60 minutes
Mean routine monitoring parameters: HR
HR for intervention period "incubator phase II"
Measured: 60 minutes
Mean routine monitoring parameters: RR
RR for intervention period "incubator phase I"
Measured: 60 minutes
Mean routine monitoring parameters: RR
RR for intervention period "SSC"
Measured: 60 minutes
Mean routine monitoring parameters: RR
RR for intervention period "incubator phase II"
Measured: 60 minutes
Mean routine monitoring parameters: MABP
MABP for intervention period "incubator phase I"
Measured: 60 minutes
Mean routine monitoring parameters: MABP
MABP for intervention period "SSC"
Measured: 60 minutes
Mean routine monitoring parameters: MABP
MABP for intervention period "incubator phase II"
Measured: 60 minutes
Mean routine monitoring parameters: temperature
Temperature for intervention period "incubator phase I"
Measured: 60 minutes
Mean routine monitoring parameters: temperature
Temperature for intervention period "SSC"
Measured: 60 minutes
Mean routine monitoring parameters: temperature
Temperature for intervention period "incubator phase II"
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Oct 2021
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Höller, MD, Principal investigator, Medical University of Graz, Department of Paediatrics and Adolescent Medicine, Devision of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865302
- Sponsor's protocol ID
- Kangaroo
- Acronym
- Kangaroo
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth - a Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT04865302
- Acronym / sponsor ID
- Kangaroo / Kangaroo
- Conditions
- Preterm Birth, Ventilator Lung; Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 29 Apr 2021 (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.
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth.
Detailed description
Background
Kangaroo mother care (KMC) or skin-to-skin care (SSC) is a routine method of care in preterm neonates in neonatal intensive care units around the world. SSC is mostly defined as the skin-to-skin contact of the infant with the mother's or father's chest, which has been proven to reduce mortality, decrease severe illness, nosocomial infections and the length of hospital stay as well as to improve growth, breastfeeding and mother-child-relationship. During the last years several studies were performed showing that SSC provides comparable neonatal physiological stability compared to routine incubator care.
Near-infrared spectroscopy (NIRS) enables non-invasive, continuous monitoring of oxygenation and perfusion in different tissues. Several studies have shown that SSC has no negative influence on cerebral oxygenation saturation and physiological parameters compared to routine incubator care in preterm infants with respiratory support after the 5th day after birth. Nevertheless, until now there is no information on cerebral oxygenation and physiological parameters during SSC compared to routine incubator care in preterm neonates with respiratory support during the first 24 hours after birth, when transition still takes place and may cause unstable vital signs in neonates. Cerebral hypoxia as well as hyperoxia can cause severe brain damage due to perfusion disturbances, especially in ventilated preterm neonates.
Objectives
Primary aim: To assess, if the burden of cerebral hypoxia (calculated as the area under the curve outside the tissue oxygenation (cStO2) target range of 55% - 76%) in preterm neonates with respiratory support is different during SSC compared to routine incubator care on the first day after birth.
Secondary aims: To assess, if SSC has an influence on cFTOE (cerebral fractional tissue oxygen extraction) and routine monitoring parameters (arterial oxygen saturation [SpO2], heart rate [HR], respiratory rate [RR], mean arterial blood pressure [MABP], temperature) in preterm neonates with respiratory support compared to routine incubator care on the first day after birth.
Methods
Study population: Preterm neonates <37+0 weeks of gestation with respiratory support admitted to the Division of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section will be eligible for the study.
Procedure: Patients and maternal medical history and main diagnoses, as well as routinely sampled laboratory results, provided therapy and respiratory support will be documented in each neonate.´
Measurements: For NIRS measurements the OxyPrem 1.4. (OxyPrem AG, Zurich, Switzerland) will be used. The NIRS measurements will take place once during the first day after birth before / during / after routine SSC and will last for 180 minutes.
After feeding the neonates will be brought in a prone position in the incubator and the NIRS sensor will be applied on the forehead for continuous cStO2 measurements throughout the study period. The neonate will rest in this position for 60 minutes. Afterwards the neonate will be brought on the mother's or father's chest (skin to skin) in a prone position and will stay in this position for 60 minutes. Finally the neonates will be brought back into the incubator for another 60 minutes in prone position. After 180 minutes the study period is over and the NIRS sensor will be removed.
Furthermore, NIRS will be combined with routine monitoring, such as pulse oxymetry (SpO2, HR), blood pressure measurements and measurements of temperature. Data will be stored in a polygraphic system (alpha-trace digitalMM, B.E.S.T. Medical Systems, Austria) for further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 minutes to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates <37+0 weeks of gestation admitted to the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section will be eligible for the study.
Key inclusion criteria (3 listed)
- Need for respiratory support (endotracheal tube [ETT], nasal continuous positive airway pressure [nCPAP], high-flow nasal cannula [HFNC])
- Decision to conduct full life support
- Written informed consent
Key exclusion criteria (6 listed)
- No decision to conduct full life support
- No written informed consent
- Severe congenital malformations, severe asphyxia (umbilical cord artery pH <7.00)
- Cerebral malformations, posthaemorrhagic ventricular dilatation, intraventricular haemorrhage grade III, periventricular haemorrhage
- Cardiovascular instability (need for catecholamines)
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 |
|---|---|---|
| SSCIncubator phase I: After feeding the neonates will be brought in a prone position in the incubator and the NIRS sensor will be applied on the forehead for continuous cStO2 measurements throughout the study period. The neonate will rest in this position for 60 minutes. SSC phase: The neonate will be brought on the mother's or father's chest (skin to skin) in a prone position and will stay in this position for 60 minutes. Incubator phase II: The neonates will be brought back into the incubator for another 60 minutes in prone position. After 180 minutes the study period is over and the NIRS sensor will be removed. | Procedure or surgery | – |
Primary outcome
percent minutes of cerebral hypoxia
Time frame: 60 minutes
After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase I" over 40 minutes.
percent minutes of cerebral hypoxia
Time frame: 60 minutes
After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "SSC" over 40 minutes.
percent minutes of cerebral hypoxia
Time frame: 60 minutes
After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase II" over 40 minutes.
21 secondary outcomes
Mean StO2
Time frame: 60 minutes
Mean StO2
Time frame: 60 minutes
Mean StO2
Time frame: 60 minutes
Mean cFTOE
Time frame: 60 minutes
Mean cFTOE
Time frame: 60 minutes
Mean cFTOE
Time frame: 60 minutes
Mean routine monitoring parameters :SpO2
Time frame: 60 minutes
Mean routine monitoring parameters :SpO2
Time frame: 60 minutes
Mean routine monitoring parameters :SpO2
Time frame: 60 minutes
Mean routine monitoring parameters: HR
Time frame: 60 minutes
Mean routine monitoring parameters: HR
Time frame: 60 minutes
Mean routine monitoring parameters: HR
Time frame: 60 minutes
Mean routine monitoring parameters: RR
Time frame: 60 minutes
Mean routine monitoring parameters: RR
Time frame: 60 minutes
Mean routine monitoring parameters: RR
Time frame: 60 minutes
Mean routine monitoring parameters: MABP
Time frame: 60 minutes
Mean routine monitoring parameters: MABP
Time frame: 60 minutes
Mean routine monitoring parameters: MABP
Time frame: 60 minutes
Mean routine monitoring parameters: temperature
Time frame: 60 minutes
Mean routine monitoring parameters: temperature
Time frame: 60 minutes
Mean routine monitoring parameters: temperature
Time frame: 60 minutes
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 2 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Nina Höller, MD principal investigator
Medical University of Graz, Department of Paediatrics and Adolescent Medicine, Devision of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Ventilator Lung; Newborn, run by Medical University of Graz at 1 site in Austria.
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 6 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 2 Dec 2024. 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 Austria. 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?
percent minutes of cerebral hypoxia (time frame: 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.