To identify alternative dEMG electrode positions in preterm infants for cardio-respiratory monitoring.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The electrical activity of the diaphragm measured on 5 different body locations
compared to standard position.
Secondary outcome
Not applicable
Background summary
Apnea of prematurity (AOP) is a result of the immaturity of the central
respiratory drive in preterm infants. Apneas can be classified into three
groups: (1) central apnea, a cease in airflow due to absence of respiratory
effort; (2) obstructive apnea, a cease in airflow caused by upper-airway
obstruction; and (3) mixed apnea, a cease in airflow caused by a combination of
both. In almost all infants these apnea are accompanied by hypoxemia and/or
bradycardia. Prolonged hypoxemic episodes are associated with an increased risk
of adverse neurodevelopmental outcome. Therefore, correct detection and
classification of apneas is important for optimal treatment.
Electrical activity of the diaphragm, the main respiratory muscle, can be
measured using transcutaneous electromyography (dEMG). Studies show that this
non-invasive measurement tool improves the accuracy of apnea classification
compared to the current standard cardio-respiratory monitoring, chest impedance
(CI), in preterm infants. In future, dEMG might replace CI for continuous
cardio-respiratory monitoring. dEMG based cardio-respiratory monitoring will
only be successful if there are enough alternative body locations with a good
dEMG signal so that repositioning of the electrodes is possible. This is
necessary to prevent damaging of the infant*s skin.
Study objective
To identify alternative dEMG electrode positions in preterm infants for
cardio-respiratory monitoring.
Study design
Prospective observational study
Study burden and risks
This study can only be done within preterm subjects because of the
physiological immaturity of the respiratory system and immature central
respiratory drive in this specific population. The study population will not
benefit from participating in this research. This study will expand our
knowledge about the alternative body positions of dEMG electrodes for
cardio-respiratory monitoring in preterm infants, what will benefit future care
and improve the implementation of this new monitoring tool for these patients.
The measurement techniques used are non-invasive and well tolerated.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Born at 26 to 37 weeks gestational age with or without respiratory support
- Only non-invasive respiratory support with a maximum FiO2 of 30% if receiving respiratory support
- Average of less than two instances of apnea per hour
- Written parental informed consent
Exclusion criteria
- Major congenital anomalies
- Clinical instability requiring frequent interventions by the nursing staff that may interfere with the measurement
- The attending physician considers the infant to be too vulnerable to participate in the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62332.018.17 |