Contact information
Type
Scientific
Primary contact
Dr A.H.L.C. Kaam, van
ORCID ID
Contact details
Academic Medical Center
Emma Children's Hospital
Department of Neonatology (Room H3-150)
P.O. Box 22700
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663971
a.h.vankaam@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Respiratory Distress Syndrome (RDS)
Intervention
Patients will be randomised to receiving either open lung or conventional positive pressure ventilation. During open lung ventilation, collapsed alveoli will be actively recruited and stabilised 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 cm H2O and a tidal volume between 4-7 ml/kg.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Oxygenation
Secondary outcome measures
1. Time to extubation
2. Incidence of air leaks
3. Incidence of hypotension
4. Incidence of treatment failure
Overall trial start date
09/01/2006
Overall trial end date
01/02/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Gestational age between 27^0/7 - 34^0/7 weeks
2. Postnatal age <12 hours
3. Mechanical ventilation for RDS
4. Informed consent
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Small for gestational age (<P3)
2. Persistent pulmonary hypertension
3. Congenital malformations
4. Severe septic shock
5. Air leak syndrome
6. Surfactant therapy prior to inclusion
Recruitment start date
09/01/2006
Recruitment end date
01/02/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19364558
Publication citations
-
Results
de Waal K, Evans N, van der Lee J, van Kaam A, Effect of lung recruitment on pulmonary, systemic, and ductal blood flow in preterm infants., J. Pediatr., 2009, 154, 5, 651-655, doi: 10.1016/j.jpeds.2009.01.012.