Maturational Changes in Newborn Infants
|ClinicalTrials.gov Identifier: NCT02501512|
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : May 13, 2016
|Condition or disease|
|Immature Newborn Abnormal Coordination|
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 Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Maturational Changes in Coordination of Breathing, Heart Rate and Swallowing in Newborn Infants - a Single-centre Pilot Study|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
- 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 ]
- 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 ]To find out whether oesophageal data has the potential to replace standard NICU monitoring.
- Change of average value of respiratory rate over the measurement period [ Time Frame: 5 consecutive days during first two weeks of life ]To evaluate whether maturational changes in respiratory rate can be determined by EMG analyses
- Change of average value of heart rate over the measurement period [ Time Frame: 5 consecutive days during first two weeks of life ]To evaluate whether maturational changes in heart rate can be determined by EMG analyses
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501512
|University Children's Hospital Basel|
|Basel, Basel Stadt, Switzerland, 4056|
|Principal Investigator:||Sven Schulzke, Prof||University Children's Hospital Basel|