A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
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|ClinicalTrials.gov Identifier: NCT00607555|
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : November 2, 2009
|Condition or disease||Intervention/treatment|
|Infant, Premature Apnea||Device: Insertion of specialized feeding tube for monitoring of EAdi|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|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|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable
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
- 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 ]
- Change in amount of phasic EAdi before and after an intermittent bolus feed [ Time Frame: Day of study ]
- Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed [ Time Frame: Day of study ]
- Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed [ Time Frame: Day of study ]
- Diaphragmatic fatigue [ Time Frame: Day of study ]
- Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed [ Time Frame: Day of study ]
- Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed [ Time Frame: Day of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607555
|Sunnybrook Health Sciences Centre|
|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|