Will CPAP Reduce Length Of Respiratory Support In Premature Infants?

NCT ID: NCT00486395

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-02-28

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.

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.

Conditions

Prematurity; Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Mechanical ventilation

Group Type: ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type: DEVICE

Volume guarantee strategy

2

CPAP

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

CPAP administered via "Bubble" method or Infant Flow Driver

Interventions

CPAP

CPAP administered via "Bubble" method or Infant Flow Driver

Intervention Type: DEVICE

Mechanical ventilation

Volume guarantee strategy

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Child and Family Research Institute

OTHER

Sponsor Role: collaborator

Children's & Women's Health Centre of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Sherlock

Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca L Sherlock, MD, FRCPC, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

Children's and Women's Health Centre of BC

Locations

The Royal Alexandra Hspital

Edmonton, Alberta, Canada

The Royal Columbian Hospital

New Westminster, British Columbia, 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, Canada

The Ottawa Hospital-General campus

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

07-08 005

Identifier Type: -

Identifier Source: org_study_id