1. Feasibility and reproducibility of transcutaneous (tc) dEMG on premature neonates. - Are the signal quality (heart rate and respiratory rate), bradycardias and apneas similar to the current impedance monitoring2. Can we differentiate between…
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Feasibility and reproducibility of tc-dEMG on premature neonates
- Differentiation between central versus obstructive apneas with tc-dEMG.
- The effect on diaphragm activity of an upload dose Caffeine or Dopram .
- The effect on diaphragm activity when changing respiratory support from nCPAP
to 'flowsnor'.
- Predictive values of success or failure by change from nCPAP to 'flowsnor'.
- Which role plays the diaphragm during neonatal pulmonary transition.
- Detection of spontaneous breaths by transcutaneous dEMG.
Secondary outcome
Not applicable
Background summary
The diaphragm is an important respiratory muscle and plays an important role in
the neonatal respiration and neonatal pulmonary transition. Transcutane
measurements of the electrical activity of the diaphragm (dEMG) gave us insight
in the control of breathing in children and neonates. However, the role of the
diaphragm in the control of breathing in preterm neonates and during the
pulmonal transition in term neonates is unclear. Therefore, dEMG in (preterm)
neonates is useful and clinically relevant.
Transcutaneous dEMG in premature neonates is feasible. This research project
investigates the physiology of control of breathing, pathophysiology of
respiratory disorders, detection of spontaneous breaths and the outcome of
respiratory and pharmacotherapy treatments in premature newborns.
The aim of this research project is to achieve improved respiratory monitoring
which will lead to improved pulmonary and neurological outcome.
In preterm and in term neonates we also investigate which role the diaphragm
plays during the neonatal pulmonary transition. This information is important
to determine the need and type of respiratory assistance at birth.
Study objective
1. Feasibility and reproducibility of transcutaneous (tc) dEMG on premature
neonates.
- Are the signal quality (heart rate and respiratory rate), bradycardias and
apneas similar to the current impedance monitoring
2. Can we differentiate between central versus obstructive apneas with tc-dEMG.
3. What is the effect on diaphragm activity after an upload dose Caffein or
Dopram.
4. What is the effect on diaphragm activity when we change respiratory support
from nCPAP to the 'flowsnor' and what are the predictive values of success or
failure by change from nCPAP to 'flowsnor'.
5. Which role plays the diaphragm during neonatal pulmonary transition measured
by tc-dEMG in term neonates.
6. Which role plays the diaphragm during neonatal pulmonary transition measured
by tc-dEMG in preterm neonates.
7. Is transcutaneous dEMG superior to the Graseby capsule in detection of
spontaneous breaths?
Study design
Observational Prospective Cohort study
Study burden and risks
Burden, benefit and risks:
Although there will be no direct benefits for enrolled patients, the results of
this study will improve our knowledge about the diaphragm during respiration
and will lead to more optimal treatments for future preterm neonates. Tc-dEMG
has been conducted by former investigators on infants and neonates in the Emma
Childrens Hospital, AMC and no burden was described. Because of the
observational, non-invasive character of tc-dEMG and because no burden was
described on infants and neonates, we assume this will be the same for our
population.
Group relatedness:
We study the role of the diaphragm in the control of breathing in (premature)
newborns. Therefore we can not perform this study in another population than
(premature) newborns.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Premature neonates GA < 37 weeks and healthy term infants
Non-invasive respiratory support or no respiratory support
Informed consent of one or both parents
Exclusion criteria
Congenital malformation of thorax, heart and/or lungs
Non-invasive or invasive (endotracheal) ventilation
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 | NL39990.018.12 |