To determine the effect of MIST on the electrical activity of the diaphragm.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in electrical activity of the diaphragm after MIST
Secondary outcome
Changes in Vt after MIST
The correlation of changes in diaphragm activity and changes in Vt after MIST.
Background summary
Respiratory distress syndrome (RDS) is a common diagnosis in preterm infants,
caused by surfactant deficiency. The treatment consist of respiratory support
and exogenous surfactant administration. Traditionally, surfactant is
administrated via an endotracheal tube. However, to prevent adverse effects of
intubation and mechanical ventilation in spontaneous breathing preterm infants
with RDS, minimally invasive surfactant therapy (MIST) becomes more common in
clinical practice. During MIST infants are non-invasively supported with nasal
continuous positive airway pressure (nCPAP). Clinically, the work of breathing,
i.e. tachypnea and dyspnea, decreases after surfactant administration due to
the improvement of lung compliance and functional residual capacity (FRC).
However, to date this decrease in work of breathing has not been objectified
with physiological measurements. Electrical activity of the diaphragm, the main
respiratory muscle, can be measured with transcutaneous electromyography
(dEMG). This non-invasive, easy to use, bedside monitoring tool is considered
to be a measure of work of breathing.
Study objective
To determine the effect of MIST on the electrical activity of the diaphragm.
Study design
Prospective observational cohort study
dEMG and respiratory inductance plethysmography (RIP ) are used to measure
diaphragm activity and tidal volume (Vt) before, during and after MIST
procedure.
Study burden and risks
This study can only be done with preterm subjects because surfactant therapy
for RDS is only used in this specific population. The study population will not
benefit from participation in this research. This study will provide
physiological information on the effect of a widely used treatment in preterm
infants, which is thought to improve and optimize future care for this patient
population. The measurement techniques used are non-invasive and well
tolerated.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Born at gestational age < 37 weeks
- Non-invasive respiratory support
- Clinical signs of RDS in first 72 hours after birth
- Indication for MIST based on our hospital protocol and ascertained by the attending physician
- Written parental consent
Exclusion criteria
- Major congenital anomalies
- 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 | NL56594.018.16 |