Will CPAP Reduce Length Of Respiratory Support In Premature Infants?

NCT00486395 | Terminated Phase 3 DMC

• 1 other identifier: 07-08 005
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 6

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.

Conditions

Prematurity; Respiratory Distress Syndrome, Newborn

Keywords

prematurity; randomized trial; RDS; surfactant; CPAP; ventilation

Outcome Measures

Primary Outcomes (1)

• Length of respiratory support

  CPAP plus MV days

  Variable

Secondary Outcomes (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

  Variable

Study Arms (2)

1

ACTIVE COMPARATOR

Mechanical ventilation

Device: Mechanical ventilation

2

EXPERIMENTAL

CPAP

Device: CPAP

Interventions

CPAP DEVICE

CPAP administered via "Bubble" method or Infant Flow Driver

2

Mechanical ventilation DEVICE

Volume guarantee strategy

1

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• Parental consent obtained.

You may not qualify if:

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

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead
• Child and Family Research Institute: collaborator

Study Sites (6)

The Royal Alexandra Hspital

Edmonton, Alberta, Canada

Location

The Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, V3L3W7, Canada

Location

Children's and Women's Health Centre of BC

Vancouver, British Columbia, V6H3V4, Canada

Location

Victoria General Hospital

Victoria, British Columbia, Canada

Location

The Ottawa Hospital-General campus

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn; Respiratory Aspiration

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

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

  Children's and Women's Health Centre of BC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

CA (6)