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
Sponsor study identifier
observational
10
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2008
Actual (reported)February 5, 2008
Actual (reported)March 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2008
Actual (reported)December 2008
Actual (reported)Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed
Day of study
Change in amount of phasic EAdi before and after an intermittent bolus feed
Day of study
Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed
Day of study
Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed
Day of study
Diaphragmatic fatigue
Day of study
Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed
Day of study
Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario, M5S1B2, Canada
Eugene Ng, MD, FRCPC
Sunnybrook Health Sciences Centre
Patti Schurr, RN, MSc
Sunnybrook Health Sciences Centre
Maureen Reilly, RRT
Sunnybrook Health Sciences Centre
Jennifer Beck, PhD
Sunnybrook Health Sciences Centre
First Submitted
February 4, 2008
First Posted
February 5, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Testing Four Feeding Approaches to Oral Feeding in Preterm Infants
Contact the study team to confirm eligibility.
Michael Dunn, MD, FRCPC
Sunnybrook Health Sciences Centre
Study Completion
December 2008
Actual (reported)Last Updated
November 2, 2009
Record last verified: 2008-09
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Source: ClinicalTrials.gov.
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