Clinical trial NCT00486395: Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
Official title: Offering Less Invasive Ventilation in Infants Born 28 to 32 Weeks Gestation: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prematurity
Respiratory Distress Syndrome, Newborn
Keywords: prematurity
randomized trial
RDS
surfactant
CPAP
ventilation
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
Collaborators: name: Child and Family Research Institute
First posted: 2007-06-14
Enrollment: 126
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Length of respiratory support
timeFrame: Variable
Secondary outcomes:
measure: 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
timeFrame: Variable
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: The Royal Alexandra Hspital
state: Alberta
city: New Westminster
country: Canada
facility: The Royal Columbian Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of BC
state: British Columbia
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital-General campus
state: Ontario
Study officials:
affiliation: Children's and Women's Health Centre of BC
name: Rebecca L Sherlock, MD, FRCPC, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: