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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
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date February 4, 2008
First Posted Date February 5, 2008
Last Update Posted Date November 2, 2009
Study Start Date March 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00607555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 4, 2008)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
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
Brief 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.

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre
Condition
  • Infant, Premature
  • Apnea
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
Study Groups/Cohorts Observation
Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable
Intervention: Device: Insertion of specialized feeding tube for monitoring of EAdi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 4, 2008)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 12 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00607555
Other Study ID Numbers 268-2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eugene Ng, MD, FRCPC, Sunnybrook Health Sciences Centre
Study Sponsor Sunnybrook Health Sciences Centre
Collaborators The Physicians' Services Incorporated Foundation
Investigators
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
PRS Account Sunnybrook Health Sciences Centre
Verification Date September 2008