NCT00607555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 2, 2009

Status Verified

September 1, 2008

Enrollment Period

9 months

First QC Date

February 4, 2008

Last Update Submit

October 30, 2009

Conditions

Infant, PrematureApnea

Keywords

Infant, prematureInfant, very low birth weightApneaFeeding methodsDiaphragm

Outcome Measures

Primary Outcomes (1)

  • Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed

    Day of study

Secondary Outcomes (6)

  • Change in amount of phasic EAdi before and after an intermittent bolus feed

    Day of study

  • Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed

    Day of study

  • Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed

    Day of study

  • Diaphragmatic fatigue

    Day of study

  • Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed

    Day of study

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Insertion of specialized feeding tube for monitoring of EAdiDEVICE

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

Observation

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre

You may qualify if:

  • Preterm infants \>23 weeks gestation
  • Birth weight \<1250 grams
  • Not requiring full mechanical ventilation
  • Tolerating full regular bolus feeding for at least 48 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5S1B2, Canada

Location

MeSH Terms

Conditions

Premature BirthApnea

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eugene Ng, MD, FRCPC

    Sunnybrook Health Sciences Centre

    STUDY CHAIR

  • Patti Schurr, RN, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Maureen Reilly, RRT

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Jennifer Beck, PhD

    Sunnybrook Health Sciences Centre

    STUDY DIRECTOR

  • Michael Dunn, MD, FRCPC

    Sunnybrook Health Sciences Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 5, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 2, 2009

Record last verified: 2008-09

Locations

CA(1)