The objective of this study is to obtain physiological data on lung aeration during pulmonary transition in newborn infants.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study parameters/endpoints
Main study parameter/endpoint
1. The change in lung aeration in the first 60 minutes after birth assessed by:
a. End-expiratory lung volume (*EELV)
b. Absolute tidal volume
c. Tidal volume distribution
2. The regional distribution of these changes in EELV and tidal volume
distribution assessed by:
a. Left to right lung ratio
b. Dependent to non-dependent lung ratio
c. Geometric Center of Ventilation (CoV)
d. Silent spaces or percentage atelectasis
Secondary outcome
1. Assess possible differences between the timing of lung aeration between term
and preterm infants based on short and long time constants (*)
2. Assess possible differences between the timing of lung aeration between
infants born via the vaginal route and those born via caesarian section
3. Assess the association between changes in lung aeration and the vital
parameters heart rate and oxygen saturation measured with pulse oximetry
(SpO2). In a subgroup of patients, we will also assess the association between
lung aeration and airway pressure and volume (see study procedure).
Background summary
During intra-uterine life, the lungs of the human fetus is fluid filled. This
fluid is necessary for normal lung development. Clearance of carbon dioxide and
delivery of oxygen is governed by the placenta connected to the fetus by the
umbilical cord. At the time of birth these conditions change dramatically. The
umbilical cord is clamped, thereby stopping gas exchange via the placenta. This
means that normal lung function is now necessary for normal gas exchange. This
process is called pulmonary transition. To make pulmonary transition a success,
the fluid that is still present at the time of birth needs be to cleared from
the lungs. Furthermore, the lungs need to be aerated and perfused in order to
start normal gas exchange. Based om studies in lambs and rabbit pups, it is
assumed that the postnatal breaths taken in the first minutes after birth are
most important in clearing the lung fluid and aerating the lungs. During each
inspiration air enters the lungs and the fluid is pushed distally via the
airways. This latter process is supported by so-called expiratory breaking.
During expiratory breaking, the infants builds up high airway pressure by
grunting or crying. This facilitates distal movement of the fluid. At that
level the fluid enters the interstitial space and is taken up by the lymphatic
vessels. If the infant is not spontaneously breathing at the time of birth, the
physician needs to support lung fluid clearance and aeration by applying
positive pressure breaths via a mask and bag. To mimic expiratory breaking,
pressure also needs to be applied during the expiratory phase of positive
pressure ventilation (positive end-expiratory pressure (PEEP)). It is clear
that the process of pulmonary transition takes time and that it is perfectly
normal that during this transition infants slowly turn pink as the lung gets
aerated. Under physiological conditions this may take up to 10 minutes.
Studies animal models and human infants have suggested that pulmonary
transition differs between infants born via the vaginal route and via caesarian
section. Furthermore, it has been suggested that fluid clearance and aeration
of the lungs is compromised in preterm infants due to immaturity of the lungs.
As previously mentioned the physiology of normal pulmonary transition is mainly
based on animal models. The most important reason for the lack of human data is
the absence of a tool to non-invasively measure changes in (regional) lung
aeration at the bedside. This has recently changed with the introduction of a
new technique called electrical impedance tomography (EIT). EIT uses 32
electrodes circumferentially placed around the chest wall. A small current is
injected between a pair of adjacent electrodes and all other electrodes measure
the voltage change. The pair of electrodes used for current injection changes
in a rotating manner. One full circle is an EIT scan and all measured voltage
changes are used to reconstruct the regional changes in lung impedance
(=resistivity to an alternating current). Aeration will have, by far, the
largest impact on impedance. EIT has a high temporal resolution (real-time
continues imaging of dynamic lung function), is radiation free and can be used
at the bedside. EIT has been studied in (preterm) neonates, infants and
children. These studies have shown that EIT imaging is feasible in this
population and that it provides reliable imaging of regional lung aeration. The
two most important parameters obtained with EIT are regional changes in
end-expiratory lung volume (EELV) and changes in the distribution of tidal
volume (tidal ventilation). Previous studies have reported no adverse effects,
making EIT use safe in this vulnerable population. Part of these studies have
been conducted in the Neonatal Intensive Care Unit (NICU) of the Emma
Children*s Hospital AMC (METC 05/069, METC 2012/079). More recently EIT has
taken another important step that allows it to be used the delivery room. The
electrodes have been integrated in a belt and no longer need to placed one by
one and stick to the skin of the patient. This means that these non-adhesive
electrodes can be place completely non-invasively and vary rapidly provide
real-time data on lung aeration.
This makes EIT the first monitoring tool that, in theory, should be ably to
monitor normal physiological pulmonary transition after birth. Knowledge on
pulmonary transition will be extremely valuable for several reasons. First,
understanding normal physiology is essential to define abnormal or compromised
pulmonary transition. Second, it also allows to identify possible interventions
to support pulmonary transition. Studies have suggested that supporting a
compromised pulmonary transition may impact the pulmonary outcome of preterm
infants.
As a first step this study aims to monitor pulmonary transition in both term
and preterm infants born either via the vaginal route or caesarian section.
Study objective
The objective of this study is to obtain physiological data on lung aeration
during pulmonary transition in newborn infants.
Study design
This is a prospective observational study conducted in the neonatal intensive
care unit of the Emma Children*s Hospital, Academic Medical Center, Amsterdam
over a period of 24 months
Study burden and risks
The burden for the included patients are as minimal as possible as it is a
observational study with interventions. The improved non-adhesive EIT belt with
sutured in electrodes has made the risk of side effects minimal. In literature
no side effects have been reported.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
o Gestational age 25 * 42 weeks
o Written informed consent from both parents or legal representatives
Exclusion criteria
o Postmenstrual age < 25 weeks
o Birth weight < 600 g
o Chest skin lesions preventing placement of electrode belt
o Acute and severe fetal distress with anticipated need for resuscitation after birth
Design
Recruitment
Medical products/devices used
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 |
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CCMO | NL60035.018.16 |