To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of positive pressure ventilation to preterm infants at birth will increase the proportion of tidal volumes within a predefined *safe range* of 4 -…
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of tidal volumes delivered during manual PPV to an infant within
the target range of safe tidal ventilation. The target range of adequate tidal
volume is defined as 4-8 mL/kg.
Secondary outcome
Secondary outcomes: clinical
- Rates of endotracheal intubation in the first 24 hours after birth
- The need for circulatory support over first 24 hours (inotropes and fluid
boluses)
- Incidence of air leak (pneumothorax, pulmonary interstitial emphysema,or
pneumomediastinum) in the first 72 hours, reported by a radiologist masked to
the intervention.
- Incidence of abnormal cranial ultrasound findings (i) all intraventricular
haemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular
haemorrhage, (iii) periventricular leukomalacia
- Duration of endotracheal (ET) ventilation (hours).
- Duration of nasal CPAP (hours).
- Duration of supplemental oxygen therapy (hours)
- Total duration of assisted ventilation (ET, CPAP) in hours
- Incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected
gestational age defined as the need for supplementary oxygen and/or any form
respiratory support. The severity of BPD will be assessed as proposed by Jobe
et al.34 and oxygen reduction test will be performed in case of moderate BPD as
described by Walsh et al35.
- Neonatal mortality - death before discharge from hospital.
- Composite outcome of death or BPD
Secondary outcomes: physiological and biochemical measurements
1. Oximetry data on SpO2 and heart rate in the first 10 minutes from birth will
be downloaded
2. Duration of significant mask leak (defined as > 60 %) as a proportion of
time face mask was used.
3. Significant airway obstruction (defined as a reduction in flow and volume (<
25th percentile of measured VTe with minimal leak during the inflation and
typical flattening of the flow waves and the PIP was unchanged) as a proportion
of the time face mask is used.
4. Occurrence of inadequate tidal volume (defined as <4 ml/kg) as a proportion
of the time face mask is used
5. Oxygen saturation (SpO2) levels between 3 and 10 minutes, recorded by a
Masimo pulse oximeter
6. FiO2 changes in the first 10 minutes
7. Total amount of pure oxygen given to the patient (oxygen load) will be
calculated taking into consideration birth weight, tidal volume, respiratory
rate, FiO2 and timing of stabilisation.
Background summary
Extremely preterm infants often fail to establish efficient gas exchange
independently in the delivery room (DR) and many receive mask ventilation or
tracheal intubation and mechanical ventilation. A tight seal between mask and
face creating a leak free ventilation circuitis important to provide effective
ventilation to the transitioning preterm infant . Leak at the mask may
contribute to inadequate ventilation or even failure of the resuscitation.
Achieving effective manual ventilation can be difficult because most clinicians
are not aware when mask leak or airway obstruction occur.With variable leaks,
variable tidal volumes are delivered that may be either inadequate or excessive
causing lung injury. Moreover, inadequate ventilation may lead to persistently
lower oxygen saturations (SpO2) prompting clinicians to increase FiO2. The
newly born infant*s lung is susceptible to pro-oxidant mediated inflammation
and administration of supplemental oxygen during neonatal resuscitation has
recently been revised to reflect this.
Traditionally, adequacy of ventilation during positive pressure ventilation
(PPV) in the DR is assessed by adequate chest rise and an increase in heart
rate. This contrasts with the assessment of optimal ventilation in the
neonatal intensive care unit. Best practice guidelines from experts state that
mechanical ventilation should be guided by a continuous display of airway
pressure, gas flow, tidal volume (VT) and gas leak at the endotracheal tube
(ETT).
Recently, it has been demonstrated that the use of a respiratory function
monitor (RFM) can guide PPV in the DR. Manikin and observational studies have
shown that a RFM enabled the clinical team to quickly recognize mask leak,
inadequate expired Vt, or airway obstruction.
However, thus far data from large randomized studies on the use of an RFM
during neonatal resuscitation are lacking. The use of an RFM in the DR has the
potential to improve neonatal respiratory support and reduce lung injury. To
prove this, a large randomized trial is needed.
Study objective
To test the hypothesis that observing the data and waveforms displayed on an
RFM during the provision of positive pressure ventilation to preterm infants at
birth will increase the proportion of tidal volumes within a predefined *safe
range* of 4 - 8 mls/kg.
Study design
Multi center, non-blinded, randomized controlled trial
Intervention
Eligible infants will be randomised to either have the respiratory function
monitor visible or covered during positive pressure ventilation for
resuscitation at birth
Study burden and risks
no extra burden or risk.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Infants born will be included in this study if they are between 24 and 27 completed weeks
gestation receiving PPV for resuscitation at birth
Exclusion criteria
if they are found to have a congenital abnormality
or condition that might have an adverse effect on breathing or ventilation, including: congenital
diaphragmatic hernia, tracheo-oesophageal fistula or cyanotic heart disease.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL43055.058.12 |