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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.

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 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

Other trials in Switzerland

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.

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.

  1. Respiratory rate determined by transoesophageal EMG

    Measured: 5 consecutive days during first two weeks of life

  2. Heart rate determined by transoesophageal ECG

    Measured: 5 consecutive days during first two weeks of life

  3. Swallowing act determined by transoesophageal EMG

    Measured: 5 consecutive days during first two weeks of life

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted17 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionMar 2016
  4. Study completionApr 2016

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
Case only
Time perspective
Prospective
Enrolment
13 participants (actual)
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

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.

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