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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.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00607555
First received: February 4, 2008
Last updated: October 30, 2009
Last verified: September 2008
  Purpose

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 Intervention
Infant, Premature
Apnea
Device: Insertion of specialized feeding tube for monitoring of EAdi

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607555

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M5S1B2
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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
  More Information

No publications provided

Responsible Party: Eugene Ng, MD, FRCPC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00607555     History of Changes
Other Study ID Numbers: 268-2007
Study First Received: February 4, 2008
Last Updated: October 30, 2009
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Infant, premature
Infant, very low birth weight
Apnea
Feeding methods
Diaphragm

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014