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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00607555
Other study ID # 268-2007
Secondary ID
Status Completed
Phase N/A
First received February 4, 2008
Last updated October 30, 2009
Start date March 2008
Est. completion date December 2008

Study information

Verified date September 2008
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Months
Eligibility Inclusion Criteria:

- Preterm infants >23 weeks gestation

- Birth weight <1250 grams

- Not requiring full mechanical ventilation

- Tolerating full regular bolus feeding for at least 48 hours

Exclusion Criteria:

- Congenital and acquired problem of the gastrointestinal tract

- Phrenic nerve injury and/or diaphragm paralysis

- Esophageal perforation/tracheoesophageal fistula

- Congenital/acquired neurological deficit and/or seizures

- Hemodynamic instability

- Congenital heart disease (including symptomatic patent ductus arteriosus)

- Undergoing treatment for sepsis or pneumonia

- Use of muscle relaxants, narcotic analgesics, or gastric motility agents

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed Day of study No
Secondary Change in amount of phasic EAdi before and after an intermittent bolus feed Day of study No
Secondary Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed Day of study No
Secondary Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed Day of study No
Secondary Diaphragmatic fatigue Day of study No
Secondary Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed Day of study No
Secondary Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed Day of study No
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