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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Austria

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.

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.

  1. 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

  2. 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

  3. 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)
  1. Mean StO2

    Mean StO2 values over 40 minutes, calculated for intervention period "incubator phase I", after washout time will be calculated

    Measured: 60 minutes

  2. Mean StO2

    Mean StO2 values over 40 minutes, calculated for intervention period "SSC", after washout time will be calculated

    Measured: 60 minutes

  3. Mean StO2

    Mean StO2 values over 40 minutes, calculated for intervention period "incubator phase II" after washout time will be calculated

    Measured: 60 minutes

  4. Mean cFTOE

    Mean cFTOE values over 40 minutes for intervention period "incubator phase I" after washout time will be calculated

    Measured: 60 minutes

  5. Mean cFTOE

    Mean cFTOE values over 40 minutes for intervention period "SSC" after washout time will be calculated

    Measured: 60 minutes

  6. Mean cFTOE

    Mean cFTOE values over 40 minutes for intervention period "incubator phase II" after washout time will be calculated

    Measured: 60 minutes

  7. Mean routine monitoring parameters :SpO2

    SpO2 for intervention period "incubator phase I"

    Measured: 60 minutes

  8. Mean routine monitoring parameters :SpO2

    SpO2 for intervention period "SSC"

    Measured: 60 minutes

  9. Mean routine monitoring parameters :SpO2

    SpO2 for intervention period "incubator phase II"

    Measured: 60 minutes

  10. Mean routine monitoring parameters: HR

    HR for intervention period "incubator phase I"

    Measured: 60 minutes

  11. Mean routine monitoring parameters: HR

    HR for intervention period "SSC"

    Measured: 60 minutes

  12. Mean routine monitoring parameters: HR

    HR for intervention period "incubator phase II"

    Measured: 60 minutes

  13. Mean routine monitoring parameters: RR

    RR for intervention period "incubator phase I"

    Measured: 60 minutes

  14. Mean routine monitoring parameters: RR

    RR for intervention period "SSC"

    Measured: 60 minutes

  15. Mean routine monitoring parameters: RR

    RR for intervention period "incubator phase II"

    Measured: 60 minutes

  16. Mean routine monitoring parameters: MABP

    MABP for intervention period "incubator phase I"

    Measured: 60 minutes

  17. Mean routine monitoring parameters: MABP

    MABP for intervention period "SSC"

    Measured: 60 minutes

  18. Mean routine monitoring parameters: MABP

    MABP for intervention period "incubator phase II"

    Measured: 60 minutes

  19. Mean routine monitoring parameters: temperature

    Temperature for intervention period "incubator phase I"

    Measured: 60 minutes

  20. Mean routine monitoring parameters: temperature

    Temperature for intervention period "SSC"

    Measured: 60 minutes

  21. 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.

  1. First posted29 Apr 2021
  2. Study start1 Oct 2021
  3. Primary completion11 Apr 2024
  4. Study completion11 Apr 2024

Resources

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)
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

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.

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