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

This study has been terminated.
(Decreasing recruitment)
Sponsor:
Collaborator:
Child and Family Research Institute
Information provided by (Responsible Party):
Rebecca Sherlock, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT00486395
First received: June 13, 2007
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Prematurity
Respiratory Distress Syndrome, Newborn
Device: CPAP
Device: Mechanical ventilation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Offering Less Invasive Ventilation in Infants Born 28 to 32 Weeks Gestation: A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • Length of respiratory support [ Time Frame: Variable ] [ Designated as safety issue: No ]
    CPAP plus MV days


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: September 2007
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mechanical ventilation
Device: Mechanical ventilation
Volume guarantee strategy
Experimental: 2
CPAP
Device: CPAP
CPAP administered via "Bubble" method or Infant Flow Driver

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.

  Eligibility

Ages Eligible for Study:   28 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486395

Locations
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
Investigators
Principal Investigator: Rebecca L Sherlock, MD, FRCPC, PhD(c) Children's and Women's Health Centre of BC
  More Information

No publications provided

Responsible Party: Rebecca Sherlock, Neonatologist, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT00486395     History of Changes
Other Study ID Numbers: 07-08 005
Study First Received: June 13, 2007
Last Updated: February 8, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's & Women's Health Centre of British Columbia:
prematurity
randomized trial
RDS
surfactant
CPAP
ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 27, 2014