Will CPAP Reduce Length Of Respiratory Support In Premature Infants?

Prematurity Clinical Trial

— OLIVIA  

Official title:

Offering Less Invasive Ventilation in Infants Born 28 to 32 Weeks Gestation: A Randomized Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00486395
• Other study ID #: 07-08 005
• Status: Terminated
• Phase: Phase 3
• First received: June 13, 2007
• Last updated: February 8, 2012
• Start date: September 2007
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Children's & Women's Health Centre of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 32 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Prematurity
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• CPAP
CPAP administered via "Bubble" method or Infant Flow Driver
• Mechanical ventilation
Volume guarantee strategy

Locations

Country	Name	City	State
Canada	The Royal Alexandra Hspital	Edmonton	Alberta
Canada	The Royal Columbian Hospital	New Westminster	British Columbia
Canada	The Ottawa Hospital-General campus	Ottawa	Ontario
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	Children's and Women's Health Centre of BC	Vancouver	British Columbia
Canada	Victoria General Hospital	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's & Women's Health Centre of British Columbia	Child and Family Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of respiratory support	CPAP plus MV days	Variable	No
Secondary	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		Variable	Yes