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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre The Physicians' Services Incorporated Foundation |
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Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00607555 |
In this study, we want to see how feeding affects breathing in small premature babies. Using a special feeding tube in the stomach, we can measure how the diaphragm (a large breathing muscle) might be affected by feeding. We also want to see if slowing down the feeding may lessen this effect.
Condition | Intervention |
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Infant, Premature Apnea |
Device: Insertion of specialized feeding tube for monitoring of EAdi |
Study Type: | Observational |
Study Design: | Case-Crossover, Prospective |
Official Title: | Observational Study on the Effects of Enteral Feeding and Feeding Methods on Respiratory Pattern as Assessed by Diaphragm Electrical Activity (EAdi) in Very Low Birth Weight Preterm Infants |
Estimated Enrollment: | 10 |
Study Start Date: | March 2008 |
Groups/Cohorts | Assigned Interventions |
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Observation
Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable
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Device: Insertion of specialized feeding tube for monitoring of EAdi
The specialized feeding tube will be inserted into the esophagus and positioned at the level of the crural diaphragm. EAdi will be measured with miniaturized coated stainless steel electrodes mounted on the feeding tube. The tube is connected to a monitor where EAdi will be recorded continuously throughout the entire study period
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Premature babies may have pauses in breathing known as apnea, which may require invasive treatment. The exact cause of apnea is unknown, and may be related to a combination of brain, gut, and lung immaturity.
Research in premature babies suggests that feeding may affect lung functions, but such effects may be lessened if feeds are given at a slower rate. Further research showed that the diaphragm, an important breathing muscle, may be fatigued by a full stomach. We speculate that, in premature babies, feeding might tire the diaphragm, thus impairing lung function and possibly causing apnea.
We plan to study 10 stable premature babies less than 23 weeks and 1.25 kilograms at birth. By inserting a special feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi before and after feeding, we want to directly measure how feeding might affect lung functions. We also want to compare feeding at the usual rate (5-15 minutes) versus a slower rate (90 minutes) to see how their effects on lung functions might differ.
This important study will help us determine the most appropriate treatment for premature babies with apnea related to feeding.
Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre
Inclusion Criteria:
Exclusion Criteria:
Contact: Maureen C Reilly, RRT | 416-323-6400 ext 4598 | maureen.reilly@sunnybrook.ca |
Contact: Eugene H Ng, MD | 416-323-6400 ext 3368 | eugene.ng@sunnybrook.ca |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M5S1B2 |
Study Chair: | Eugene Ng, MD, FRCPC | Sunnybrook Health Sciences Centre |
Principal Investigator: | Patti Schurr, RN, MSc | Sunnybrook Health Sciences Centre |
Principal Investigator: | Maureen Reilly, RRT | Sunnybrook Health Sciences Centre |
Study Director: | Jennifer Beck, PhD | Sunnybrook Health Sciences Centre |
Study Director: | Michael Dunn, MD, FRCPC | Sunnybrook Health Sciences Centre |
Responsible Party: | Sunnybrook Health Sciences Centre ( Eugene Ng, MD, FRCPC ) |
Study ID Numbers: | 268-2007 |
Study First Received: | February 4, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00607555 History of Changes |
Health Authority: | Canada: Health Canada |
Infant, premature Infant, very low birth weight Apnea Feeding methods Diaphragm |
Body Weight Birth Weight Signs and Symptoms Apnea |
Body Weight Birth Weight Signs and Symptoms |