No registrations found.
ID
Source
Brief title
Health condition
respiratory distress syndrome (RDS), mechanical ventilation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Oxygenation.
Secondary outcome
1. Time to extubation;
2. Incidence of air leaks;
3. Incidence of hypotension;
4. Incidence of treatment failure.
Background summary
Secondary lung injury by mechanical ventilation is considered an important risk factor in the development of bronchopulmonary dysplasia (BPD) in preterm infants. Preventing atelectasis and alveolar overdistension (open lung) might reduce the risk for BPD. This open lung ventilation strategy has so far only been used during high-frequency ventilation. Animal studies showed that this approach is also feasible during positive pressure ventilation. This pilot study tries to confirm these findings in preterm infants with RDS, as a first step to a large multicenter randomized controlled trial exploring the long term outcome parameters of open lung positive pressure ventilation.
Study objective
We hypothesize that alveolar recruitment and stabilization (open lung) is feasible during positive pressure ventilation of preterm infants and improves gas exchange compared with conventional positive pressure ventilation.
Study design
N/A
Intervention
Patients will be randomized to receiving either open lung or conventional positive pressure ventilation. During open lung ventilation, collapsed alveoli will be actively recruited and stabilized with sufficient airway pressures. In addition, tidal volumes will be reduced as much as possible, while using high ventilatory rates. During conventional ventilation patients will receive the standard of care using a positive end-expiratory pressure of 5 cmH2O and a tidal volume between 4-7 ml/kg.
P.O. Box 22660
A.H.L.C. Kaam, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663971
a.h.vankaam@amc.uva.nl
P.O. Box 22660
A.H.L.C. Kaam, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663971
a.h.vankaam@amc.uva.nl
Inclusion criteria
1. Gestational age between 27 0/7-34 0/7;
2. Postnatal age < 12 h;
3. Mechanical ventilation for RDS;
4. Informed consent.
Exclusion criteria
1. Small for gestational age (less than P3);
2. Persistent pulmonary hypertension;
3. Congenital malformations;
4. Severe septic shock;
5. Air leak syndrome;
6. Surfactant therapy prior to inclusion.
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 |
---|---|
NTR-new | NL507 |
NTR-old | NTR549 |
Other | : N/A |
ISRCTN | ISRCTN78613200 |