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

Infant, Premature Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607555
• Other study ID #: 268-2007
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: October 30, 2009
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: September 2008
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Birth Weight
• Infant, Premature

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed		Day of study	No
Secondary	Change in amount of phasic EAdi before and after an intermittent bolus feed		Day of study	No
Secondary	Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed		Day of study	No
Secondary	Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed		Day of study	No
Secondary	Diaphragmatic fatigue		Day of study	No
Secondary	Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed		Day of study	No
Secondary	Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed		Day of study	No