Open lung positive pressure ventilation in neonatal respiratory distress syndrome
| ISRCTN | ISRCTN78613200 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78613200 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 19/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.H.L.C. Kaam, van
Scientific
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 |
|---|---|
| a.h.vankaam@amc.uva.nl |
Study information
| Study design | Randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Oxygenation |
| Secondary outcome measures | 1. Time to extubation 2. Incidence of air leaks 3. Incidence of hypotension 4. Incidence of treatment failure |
| Overall study start date | 09/01/2006 |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC), Emma Children's Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neonatology
Amsterdam
-
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
