Will CPAP Reduce Length Of Respiratory Support In Premature Infants? (OLIVIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00486395
Recruitment Status : Terminated (Decreasing recruitment)
First Posted : June 14, 2007
Last Update Posted : February 10, 2012
Child and Family Research Institute
Information provided by (Responsible Party):
Rebecca Sherlock, Children's & Women's Health Centre of British Columbia

Brief Summary:
In Canada each year, there are approximately 800 infants born between 28 and 32 weeks gestation. Up to 60% of these infants will require breathing tube placement for Respiratory Distress Syndrome or RDS. RDS is a lung disease of prematurity due to a lack of a compound called surfactant. The breathing tube is placed as a conduit for placing surfactant into the babies' lungs to improve the lung disease. Most babies are then placed on a breathing machine or ventilator. Ventilation is not without harm and can be associated with lung damage, delays in feeding, increased hospital stay and interruption of bonding. An alternative that does not require the presence of a breathing tube is Continuous Positive Airway Pressure (CPAP). We will randomize babies to either ventilation or CPAP to try to minimize the length of time the baby is kept on respiratory support.

Condition or disease Intervention/treatment Phase
Prematurity Respiratory Distress Syndrome, Newborn Device: CPAP Device: Mechanical ventilation Phase 3

Detailed Description:

Objectives: To determine whether infants 28 to 32 weeks gestational age with RDS treated with surfactant followed by CPAP have a shorter length of respiratory support (length of time on a ventilator and CPAP) than similar infants who are treated with MV after surfactant therapy; and to examine secondary outcomes including outcomes related to lung disease, feeding issues and hospital length of stay (secondary outcomes).

Hypothesis: The use of CPAP after surfactant in infants born 28 to 32 weeks with RDS will reduce the length of respiratory support as compared with infants treated with MV. We hypothesize that the incidence of lung disease and feeding issues will be similar between groups while length of hospital stay will be shorter in the CPAP group.

Methods: A multi-center, randomized trial conducted in seven neonatal intensive care units in Canada and France. Parents will be approached for consent prior to delivery or after the infant shows signs of RDS. Infants 28 to 32 weeks gestation with RDS will be eligible for the study. After intubation and surfactant administration, babies will be randomized to either receive CPAP or MV. Strict criteria for CPAP failure, weaning ventilation and weaning and discontinuing CPAP will be specified. Infants will be followed in the nursery until hospital discharge or until all outcomes have been determined.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Offering Less Invasive Ventilation in Infants Born 28 to 32 Weeks Gestation: A Randomized Controlled Trial.
Study Start Date : September 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Active Comparator: 1
Mechanical ventilation
Device: Mechanical ventilation
Volume guarantee strategy

Experimental: 2
Device: CPAP
CPAP administered via "Bubble" method or Infant Flow Driver

Primary Outcome Measures :
  1. Length of respiratory support [ Time Frame: Variable ]
    CPAP plus MV days

Secondary Outcome Measures :
  1. Duration of ventilation, duration of oxygen therapy, pneumothorax rate and BPD by Walsh test, time to full feeds, time to regain birthweight, necrotizing enterocolitis, time to discharge, achievement of readiness for discharge criteria [ Time Frame: Variable ]

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Ages Eligible for Study:   28 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Infants born greater than or equal to 28 weeks (28+0) and less than 32 weeks (31+6) gestation admitted to the NICU at a participating center
  2. Diagnosis of RDS in the first 24 hours of life requiring intubation for surfactant administration by any combination of the following: Classic clinical signs of RDS include tachypnea, moderate to severe intercostal and subcostal retractions, grunting respirations and oxygen needs of >0.30 and/or on CPAP of 5 to 6 H2O cm and/or radiographic signs of RDS including low lung volumes, a reticular-granular pattern of lung infiltrates and air bronchograms. A chest radiograph is not a mandatory criterion for the diagnosis of RDS if clinical signs are present
  3. Parental consent obtained.

Exclusion Criteria:

  1. Infants with a major congenital anomaly
  2. Infants with pulmonary hypoplasia; 3. Infants known or suspected to have a neuromuscular disorder;
  3. Infants from mothers that had greater than 2 weeks ruptured membranes.
  4. Infants that had vigourous resuscitation including chest compressions and cardiac meds.
  5. No parental consent obtained.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00486395

Canada, Alberta
The Royal Alexandra Hspital
Edmonton, Alberta, Canada
Canada, British Columbia
The Royal Columbian Hospital
New Westminster, British Columbia, Canada
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3L3W7
Children's and Women's Health Centre of BC
Vancouver, British Columbia, Canada, V6H3V4
Victoria General Hospital
Victoria, British Columbia, Canada
Canada, Ontario
The Ottawa Hospital-General campus
Ottawa, Ontario, Canada
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
Child and Family Research Institute
Principal Investigator: Rebecca L Sherlock, MD, FRCPC, PhD(c) Children's and Women's Health Centre of BC

Responsible Party: Rebecca Sherlock, Neonatologist, Children's & Women's Health Centre of British Columbia Identifier: NCT00486395     History of Changes
Other Study ID Numbers: 07-08 005
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Rebecca Sherlock, Children's & Women's Health Centre of British Columbia:
randomized trial

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications