Maturational Changes in Newborn Infants
Condition: Immature Newborn; Abnormal Coordination
Study type: Observational

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). 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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
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.
      
Keywords: transesophageal signal; swallowing; newborn