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.
ID
Bron
Verkorte titel
Aandoening
respiratory distress syndrome (RDS), mechanical ventilation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Oxygenation.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Gestational age between 27 0/7-34 0/7;
2. Postnatal age < 12 h;
3. Mechanical ventilation for RDS;
4. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL507 |
NTR-old | NTR549 |
Ander register | : N/A |
ISRCTN | ISRCTN78613200 |