Clinical trial NCT00607555: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Apnea
Keywords: Infant, premature
Infant, very low birth weight
Apnea
Feeding methods
Diaphragm
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2008-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre

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.

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

Primary outcomes:
measure: Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed
timeFrame: Day of study
Secondary outcomes:
measure: Change in amount of phasic EAdi before and after an intermittent bolus feed
timeFrame: Day of study
measure: Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed
timeFrame: Day of study
measure: Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed
timeFrame: Day of study
measure: Diaphragmatic fatigue
timeFrame: Day of study
measure: Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed
timeFrame: Day of study
measure: Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed
timeFrame: Day of study
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Eugene Ng, MD, FRCPC
role: STUDY_CHAIR
affiliation: Sunnybrook Health Sciences Centre
name: Patti Schurr, RN, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Maureen Reilly, RRT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Jennifer Beck, PhD
role: STUDY_DIRECTOR
affiliation: Sunnybrook Health Sciences Centre
name: Michael Dunn, MD, FRCPC
role: STUDY_DIRECTOR
References: