COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607555
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : November 1, 2009
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Infant, Premature Apnea Device: Insertion of specialized feeding tube for monitoring of EAdi

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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
Study Start Date : March 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Observation
Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in amount of phasic EAdi before and after an intermittent bolus feed [ Time Frame: Day of study ]
  2. Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed [ Time Frame: Day of study ]
  3. Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed [ Time Frame: Day of study ]
  4. Diaphragmatic fatigue [ Time Frame: Day of study ]
  5. Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed [ Time Frame: Day of study ]
  6. Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed [ Time Frame: Day of study ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607555


Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M5S1B2
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Eugene Ng, MD, FRCPC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00607555    
Other Study ID Numbers: 268-2007
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: November 1, 2009
Last Verified: September 2008
Keywords provided by Sunnybrook Health Sciences Centre:
Infant, premature
Infant, very low birth weight
Apnea
Feeding methods
Diaphragm
Additional relevant MeSH terms:
Layout table for MeSH terms
Birth Weight
Body Weight