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

Sponsor:	Sunnybrook Health Sciences Centre
Collaborator:	The Physicians' Services Incorporated Foundation
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00607555

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:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

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

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

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:

Apnea
Birth Weight
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Body Weight

ClinicalTrials.gov processed this record on February 12, 2012