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Open lung positive pressure ventilation in neonatal respiratory distress syndrome.


- candidate number1895
- NTR NumberNTR549
- ISRCTNISRCTN78613200
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR15-dec-2005
- Secondary IDsN/A 
- Public TitleOpen lung positive pressure ventilation in neonatal respiratory distress syndrome.
- Scientific TitleOpen lung positive pressure ventilation in neonatal respiratory distress syndrome.
- ACRONYMN/A
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedRespiratory distress syndrome (RDS)
- Inclusion criteria1. Gestational age between 27 0/7-34 0/7;
2. Postnatal age < 12 h;
3. Mechanical ventilation for RDS;
4. Informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-jan-2006
- planned closingdate1-feb-2007
- Target number of participants30
- InterventionsPatients 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.
- Primary outcomeOxygenation.
- Secondary outcome1. Time to extubation;
2. Incidence of air leaks;
3. Incidence of hypotension;
4. Incidence of treatment failure.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. A.H.L.C. Kaam, van
- CONTACT for SCIENTIFIC QUERIESDr. A.H.L.C. Kaam, van
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital, Department of Neonatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summarySecondary 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.
- Main changes (audit trail)
- RECORD15-dec-2005 - 16-nov-2009


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