Trials / Completed
CompletedNCT00607555
A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- All
- Age
- 1 Day – 12 Months
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-02-05
- Last updated
- 2009-11-02
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00607555. Inclusion in this directory is not an endorsement.