Open lung positive pressure ventilation in neonatal respiratory distress syndrome

ISRCTN	ISRCTN78613200
DOI	https://doi.org/10.1186/ISRCTN78613200
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC), Emma Children's Hospital (Netherlands)
Funder	Academic Medical Centre (AMC) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A.H.L.C. Kaam, van
Scientific

Academic Medical Center
Emma Children's Hospital
Department of Neonatology (Room H3-150)
P.O. Box 22700
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5663971
Email	a.h.vankaam@amc.uva.nl

Primary study design	Interventional
Study design	Randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Oxygenation
Key secondary outcome measure(s)	1. Time to extubation 2. Incidence of air leaks 3. Incidence of hypotension 4. Incidence of treatment failure
Completion date	01/02/2007

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	09/01/2006
Date of final enrolment	01/02/2007

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No