Condition category
Neonatal Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Academic Medical Centre (AMC), Emma Children's Hospital (Netherlands)

Sponsor details

Department of Neonatology
Amsterdam
-
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes