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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Apnea; Infant, Premature

Treatments: Device: Insertion of specialized feeding tube for monitoring of EAdi

Study type: Observational

Funder types: Other

Identifiers

NCT00607555

268-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Observation

Description:

Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable

Treatment:

Device: Insertion of specialized feeding tube for monitoring of EAdi