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A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
This study has been completed.
Study NCT00607555   Information provided by Sunnybrook Health Sciences Centre
First Received: February 4, 2008   Last Updated: October 30, 2009   History of Changes

February 4, 2008
October 30, 2009
March 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00607555 on ClinicalTrials.gov Archive Site
  • Change in amount of phasic EAdi before and after an intermittent bolus feed [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Diaphragmatic fatigue [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed [ Time Frame: Day of study ] [ Designated as safety issue: No ]
Same as current
 
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

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.

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.

 
Observational
Case-Crossover, Prospective
  • Infant, Premature
  • Apnea
Device: Insertion of specialized feeding tube for monitoring of EAdi
Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
up to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00607555
Eugene Ng, MD, FRCPC, Sunnybrook Health Sciences Centre
268-2007
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
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
Sunnybrook Health Sciences Centre
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP