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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | February 4, 2008 | ||||||||||||||||||||
| Last Updated Date | October 30, 2009 | ||||||||||||||||||||
| Start Date ICMJE | March 2008 | ||||||||||||||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed [ Time Frame: Day of study ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00607555 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants | ||||||||||||||||||||
| Official Title ICMJE | 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 | ||||||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Case-Crossover, Prospective | ||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Insertion of specialized feeding tube for monitoring of EAdi | ||||||||||||||||||||
| Study Arms / Comparison Groups | Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable | ||||||||||||||||||||
| Publications * | |||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||||||||||||||
| Completion Date | December 2008 | ||||||||||||||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | up to 12 Months | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00607555 | ||||||||||||||||||||
| Responsible Party | Eugene Ng, MD, FRCPC, Sunnybrook Health Sciences Centre | ||||||||||||||||||||
| Study ID Numbers ICMJE | 268-2007 | ||||||||||||||||||||
| Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||||||||||||||||||
| Collaborators ICMJE | The Physicians' Services Incorporated Foundation | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Sunnybrook Health Sciences Centre | ||||||||||||||||||||
| Verification Date | September 2008 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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