Infant, PrematureNCT00607555
A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
An observational study of Infant, Premature and Apnea, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Infant, Premature, Apnea
- What is being tested?
- Insertion of specialized feeding tube for monitoring of EAdi
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre
Who may be able to join
- Preterm infants >23 weeks gestation
- Birth weight <1250 grams
- Not requiring full mechanical ventilation
- Tolerating full regular bolus feeding for at least 48 hours
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infant, Premature, Apnea
- Being tested
- Insertion of specialized feeding tube for monitoring of EAdi
- Keywords
- Infant, premature, Infant, very low birth weight, Apnea, Feeding methods, Diaphragm
- Medical subject headings
- Premature Birth, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Observation | Premature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable Receives: Device: Insertion of specialized feeding tube for monitoring of EAdi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amount of tonic electrical activity of the diaphragm (EAdi) from baseline during and after an intermittent bolus feed
Measured: Day of study
Secondary outcomes (6)
Change in amount of phasic EAdi before and after an intermittent bolus feed
Measured: Day of study
Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed
Measured: Day of study
Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed
Measured: Day of study
Diaphragmatic fatigue
Measured: Day of study
Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed
Measured: Day of study
Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed
Measured: Day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Eugene Ng, MD, FRCPC, Study chair, Sunnybrook Health Sciences CentrePatti Schurr, RN, MSc, Principal investigator, Sunnybrook Health Sciences CentreMaureen Reilly, RRT, Principal investigator, Sunnybrook Health Sciences CentreJennifer Beck, PhD, Study director, Sunnybrook Health Sciences CentreMichael Dunn, MD, FRCPC, Study director, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607555
- Sponsor's protocol ID
- 268-2007
- Status last verified
- Sep 2008
- First submitted
- 4 Feb 2008
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00607555
- Acronym / sponsor ID
- 268-2007
- Conditions
- Infant, Premature, Apnea
- Keywords
- Infant, premature, Infant, very low birth weight, Apnea, Feeding methods, Diaphragm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Device: Insertion of specialized feeding tube for monitoring of EAdiPremature infants over 23 weeks of gestation and less than 1.25 kilograms at birth, who are tolerating feedings, and are clinically stable |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health Sciences Centre
Key inclusion criteria (4 listed)
- Preterm infants >23 weeks gestation
- Birth weight <1250 grams
- Not requiring full mechanical ventilation
- Tolerating full regular bolus feeding for at least 48 hours
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of specialized feeding tube for monitoring of EAdiThe 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 | Device | Observation |
Primary outcome
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
6 secondary outcomes
Change in amount of phasic EAdi before and after an intermittent bolus feed
Time frame: Day of study
Change in the number of apnea episodes on the EAdi waveform before and after an intermittent bolus feed
Time frame: Day of study
Changes in tonic and phasic EAdi, and apnea between intermittent bolus and intermittent slow-bolus feed
Time frame: Day of study
Diaphragmatic fatigue
Time frame: Day of study
Episodes of clinically significant apnea between intermittent bolus and intermittent slow bolus feed
Time frame: Day of study
Episodes of regurgitation or vomiting between intermittent bolus and intermittent slow bolus feed
Time frame: Day of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Ng, MD, FRCPC study chair
Sunnybrook Health Sciences Centre
Patti Schurr, RN, MSc principal investigator
Sunnybrook Health Sciences Centre
Maureen Reilly, RRT principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature and Apnea, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2009.