In this multicenter trial we compare resuscitation of preterm neonates with either 5 cm H2O PEEP or 8 cmH2O PEEP. We think resuscitation with 8 cmH2O PEEP results in a better outcome compared to resuscitation with 5 cmH2O PEEP.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome is defined as the need for intubation within 72 hours after
birth.
Secondary outcome
Secondary outcomes are the duration of mechanical ventilation, need of
surfactant treatment, bronchopulmonary dysplasia, cranial ultrasound
abnormalities, retinopathy of prematurity, necrotizing enterocolitis, air leaks
and mortality.
Background summary
The use of positive end expiratory pressure (PEEP) is a recent development in
the resuscitation of newborn neonates. PEEP creates a positive pressure in the
alveoli during exhaling, preventing the neonatal lungs from collapse.
Furthermore, neonatal lungs are fluid filled after delivery. PEEP *pushes*
fluid in intracellular cavity. Recently, a study showed that resuscitation with
a nasopharyngeal tube, controlled inflation and a consistent PIP and PEEP
should be preferred compared to conventional balloon and mask resuscitation.
Neonates needed less intubation <72 hours post partum, less mechanical
ventilation, less surfactant and developed less bronchopulmonay dysplasia
(BPD). In lamb studies, resuscitation with 8 cmH2O PEEP was significantly
superior to resuscitation with 4 cmH2O PEEP.
Study objective
In this multicenter trial we compare resuscitation of preterm neonates with
either 5 cm H2O PEEP or 8 cmH2O PEEP. We think resuscitation with 8 cmH2O PEEP
results in a better outcome compared to resuscitation with 5 cmH2O PEEP.
Study design
A double-blinded, randomized controlled multicenter trial.
Intervention
We compare breathing assistance or resuscitation in the neonate with either 5
cmH2O PEEP or 8 cmH2O PEEP.
Study burden and risks
The neonates in the study will not be exposed to extra tests compared to normal
neonates in the neonatal intensive care unit (NICU). Infants in the study
receive the high care of the NICU. It is not possible to perform this study on
adults as they cannot be compared to neonatal lungs which are fluid filled and
are surfactant deficient just after birth. Our hypothesis is that subjects
have a chance of receiving better resuscitation compared to infants in current
resuscitation practices. Increased PEEP could theoretically give an increased
risk of pneumothoraces. However, previous studies showed a tendency, not
significant, to less pneumothoraces.
P Debyelaan 25
6202 AZ
NL
P Debyelaan 25
6202 AZ
NL
Listed location countries
Age
Inclusion criteria
Preterm infants with a gestational age of < 30 0/7 weeks
Exclusion criteria
any major congenital malformations at 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
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In other registers
Register | ID |
---|---|
CCMO | NL22217.068.10 |