Immature NewbornNCT02501512
Maturational Changes in Newborn Infants
An observational study of Immature Newborn and Abnormal Coordination, run by Sven Schulzke at 1 site in Switzerland.
Trial summary
This study aims to extract and discriminate the signals of respiration, heart rate and swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube. These signals will be compared with the standard monitoring signals in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 4 to 10 days
- Conditions the study is for
- Immature Newborn, Abnormal Coordination
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Apr 2016
- 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 4 to 10 days
- All sexes
- No healthy volunteers
- Child
Study population: 15 infants hospitalized in the NICU of the University Children's Hospital Basel who were born between 32 and 42 weeks gestational age in the course of their first two weeks of life.
Who may be able to join
- Informed Consent by legal representatives as documented by signature
- Gestational age of 32 to 42 weeks
- Study start possible in the course of participant's 4th-10th day of life
- Presumed NICU stay ≥ 5 days from study start onwards
- Need for a gastric feeding tube for clinical reasons for ≥ 5 days from study start onwards
Who cannot join
- Major congenital malformations
- Circulatory instability (in need of therapy with vasoactive substances)
- Endotracheal ventilation
- Infant in extremis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Basel
Basel, Canton of Basel-City, 4056
About this study
Official title: Maturational Changes in Coordination of Breathing, Heart Rate and Swallowing in Newborn Infants - a Single-centre Pilot Study
This study aims to extract and discriminate the signals of respiration, heart rate and swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube. These signals will be compared with the standard monitoring signals in the neonatal intensive care unit (NICU). Further, they will be used to search for objectively quantifiable maturational coordination processes of respiration, heart rate and swallowing. Lastly, this study aims to identify changes in ECG/EMG-signals as a result of external stimuli (e.g. nursing interventions) in the NICU.
Read the detailed description
Coordination of respiration, heart rate and swallowing in preterm and term neonates has been subject of various studies in the past; its impeccable functioning is a key criterion to be fulfilled before infants are discharged home from the NICU. Whether coordination abilities depend only on gestational age and how they can be diagnosed objectively remains controversial. Also, the ideal time point of starting to introduce suck feeds and to challenge coordination of breathing and swallowing is unknown and largely remains a matter of trial and error with the risk of causing iatrogenic aspirations of milk if babies are not ready for suck feeds. Successful coordination of swallowing and breathing is generally considered as a higher neurological function and it does represent a mile stone in overall child development. Therefore, measurement of its level of functioning could have the potential to serve as a predictor for neurological outcome. However, it is yet unknown to what extent difficulties in preterm infants allow predictions concerning their neurological development and future outcome. One of the major reasons for these unsolved questions lies in the lack of diagnostic tools to objectively measure suck-swallow-breathing coordination with sufficient accuracy, which make a precise analysis of coordination patterns in preterm infants almost impossible. Considering the relevance of these questions, it seems important to develop tools to observe coordination of breathing, heart rate and swallowing in neonates with possibly greater accuracy.
In this single-centre pilot study 15 preterm infants of 32 to 42 weeks gestational age will be included. Transesophageal ECG and EMG signals will be measured using an Edi-gastric tube (Maquet, Getinge Group, Solna Sweden), a CE-certified neonatal gastric tube equipped with electrodes. Due to the proximity of the esophageal electrodes within the gastric tube to the heart and diaphragm, esophageal ECG and EMG signals can be acquired and are probably less susceptible to motion artefacts of the baby than the commonly used skin electrodes. This is well known from measurements in adults. Moreover, motion of esophageal electrodes due to peristalsis, respiration and cardiac motion superimposes the ECG as baseline wander and might be a surrogate for the coordination abilities of preterm infants.
Using these novel esophageal data this study's goal is to obtain objective data representing maturational patterns of breathing, heart rate, and swallowing in preterm infants. Possibly derived coordination patterns might help to guide nurses and clinicians to introduce suck feeds and to develop specific early intervention strategies. Furthermore, if the gastric tube-EMG proves to be accessible in real time, it could potentially replace standard monitoring tools that require the use of skin electrodes in the future. This would not only facilitate nursing and preserve skin integrity but also simplify bonding between the parents and their infants in the NICU.
- Conditions
- Immature Newborn, Abnormal Coordination
- Keywords
- transesophageal signal, swallowing, newborn
- Medical subject headings
- Ataxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate determined by transoesophageal EMG
Measured: 5 consecutive days during first two weeks of life
Heart rate determined by transoesophageal ECG
Measured: 5 consecutive days during first two weeks of life
Swallowing act determined by transoesophageal EMG
Measured: 5 consecutive days during first two weeks of life
Secondary outcomes (3)
Agreement of beat-to-beat heart rate (inter-beat-interval) obtained from EMG signals with corresponding values from NICU monitoring
To find out whether oesophageal data has the potential to replace standard NICU monitoring.
Measured: 5 consecutive days during first two weeks of life
Change of average value of respiratory rate over the measurement period
To evaluate whether maturational changes in respiratory rate can be determined by EMG analyses
Measured: 5 consecutive days during first two weeks of life
Change of average value of heart rate over the measurement period
To evaluate whether maturational changes in heart rate can be determined by EMG analyses
Measured: 5 consecutive days during first two weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature NewbornStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sven Schulzke
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor-investigator, Sven Schulzke, University Hospital, Basel, Switzerland
- Investigators
- Sven Schulzke, Prof, Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501512
- Sponsor's protocol ID
- 2015136
- Status last verified
- May 2016
- First submitted
- 9 Jul 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maturational Changes in Coordination of Breathing, Heart Rate and Swallowing in Newborn Infants - a Single-centre Pilot Study
- ClinicalTrials.gov ID
- NCT02501512
- Acronym / sponsor ID
- 2015136
- Conditions
- Immature Newborn, Abnormal Coordination
- Keywords
- transesophageal signal, swallowing, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sven SchulzkeUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- 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 study aims to extract and discriminate the signals of respiration, heart rate and swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube. These signals will be compared with the standard monitoring signals in the neonatal intensive care unit (NICU). Further, they will be used to search for objectively quantifiable maturational coordination processes of respiration, heart rate and swallowing. Lastly, this study aims to identify changes in ECG/EMG-signals as a result of external stimuli (e.g. nursing interventions) in the NICU.
Detailed description
Coordination of respiration, heart rate and swallowing in preterm and term neonates has been subject of various studies in the past; its impeccable functioning is a key criterion to be fulfilled before infants are discharged home from the NICU. Whether coordination abilities depend only on gestational age and how they can be diagnosed objectively remains controversial. Also, the ideal time point of starting to introduce suck feeds and to challenge coordination of breathing and swallowing is unknown and largely remains a matter of trial and error with the risk of causing iatrogenic aspirations of milk if babies are not ready for suck feeds. Successful coordination of swallowing and breathing is generally considered as a higher neurological function and it does represent a mile stone in overall child development. Therefore, measurement of its level of functioning could have the potential to serve as a predictor for neurological outcome. However, it is yet unknown to what extent difficulties in preterm infants allow predictions concerning their neurological development and future outcome. One of the major reasons for these unsolved questions lies in the lack of diagnostic tools to objectively measure suck-swallow-breathing coordination with sufficient accuracy, which make a precise analysis of coordination patterns in preterm infants almost impossible. Considering the relevance of these questions, it seems important to develop tools to observe coordination of breathing, heart rate and swallowing in neonates with possibly greater accuracy.
In this single-centre pilot study 15 preterm infants of 32 to 42 weeks gestational age will be included. Transesophageal ECG and EMG signals will be measured using an Edi-gastric tube (Maquet, Getinge Group, Solna Sweden), a CE-certified neonatal gastric tube equipped with electrodes. Due to the proximity of the esophageal electrodes within the gastric tube to the heart and diaphragm, esophageal ECG and EMG signals can be acquired and are probably less susceptible to motion artefacts of the baby than the commonly used skin electrodes. This is well known from measurements in adults. Moreover, motion of esophageal electrodes due to peristalsis, respiration and cardiac motion superimposes the ECG as baseline wander and might be a surrogate for the coordination abilities of preterm infants.
Using these novel esophageal data this study's goal is to obtain objective data representing maturational patterns of breathing, heart rate, and swallowing in preterm infants. Possibly derived coordination patterns might help to guide nurses and clinicians to introduce suck feeds and to develop specific early intervention strategies. Furthermore, if the gastric tube-EMG proves to be accessible in real time, it could potentially replace standard monitoring tools that require the use of skin electrodes in the future. This would not only facilitate nursing and preserve skin integrity but also simplify bonding between the parents and their infants in the NICU.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 15 infants hospitalized in the NICU of the University Children's Hospital Basel who were born between 32 and 42 weeks gestational age in the course of their first two weeks of life.
Key inclusion criteria (5 listed)
- Informed Consent by legal representatives as documented by signature
- Gestational age of 32 to 42 weeks
- Study start possible in the course of participant's 4th-10th day of life
- Presumed NICU stay ≥ 5 days from study start onwards
- Need for a gastric feeding tube for clinical reasons for ≥ 5 days from study start onwards
Key exclusion criteria (4 listed)
- Major congenital malformations
- Circulatory instability (in need of therapy with vasoactive substances)
- Endotracheal ventilation
- Infant in extremis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory rate determined by transoesophageal EMG
Time frame: 5 consecutive days during first two weeks of life
Heart rate determined by transoesophageal ECG
Time frame: 5 consecutive days during first two weeks of life
Swallowing act determined by transoesophageal EMG
Time frame: 5 consecutive days during first two weeks of life
3 secondary outcomes
Agreement of beat-to-beat heart rate (inter-beat-interval) obtained from EMG signals with corresponding values from NICU monitoring
Time frame: 5 consecutive days during first two weeks of life
Change of average value of respiratory rate over the measurement period
Time frame: 5 consecutive days during first two weeks of life
Change of average value of heart rate over the measurement period
Time frame: 5 consecutive days during first two weeks of life
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 13 May 2016.
- Individual participant dataSharing planned: No
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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.
Sven Schulzke, Prof principal investigator
University Children's Hospital Basel
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 Immature Newborn and Abnormal Coordination, run by Sven Schulzke at 1 site in Switzerland.
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 5 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 13 May 2016. 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 Switzerland. 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?
Respiratory rate determined by transoesophageal EMG (time frame: 5 consecutive days during first two weeks of life). 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 13 May 2016.