Clinical Trials Directory

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

TypeNameDescription
DEVICEInsertion of specialized feeding tube for monitoring of EAdiThe 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.