Gastroesophageal RefluxSEGANNCT01825473
Study of Erythromycin in GER-Associated Apnea of the Newborn
A study testing Erythromycin and Multi-channel intra-luminal impedance (MII) pH monitoring in people with Gastroesophageal Reflux and Apnea, run by University of Virginia at 1 site in United States.
Trial summary
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective randomized controlled trial. Read more about this study
- Who is it for?
- Ages 14 days and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux, Apnea, Bradycardia
- What is being tested?
- Erythromycin and Multi-channel intra-luminal impedance (MII) pH monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2014
- Phase
- Interventional
- 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 14 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- major central nervous system, gastrointestinal, or complex cardiac anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Children's Hospital
Charlottesville, Virginia, 22903
Fara Davalian, MD
David A Kaufman, MD
About this study
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective randomized controlled trial.
Read the detailed description
A randomized placebo-controlled trial to determine whether erythromycin, a drug known to enhance gut motility, will improve the incidence of GER and GER-associated apnea, bradycardiac and/or hypoxic events. The investigators have two aims: 1) to examine the relationship between GER and apnea, bradycardia, and/or desaturation (ABD) events by simultaneously employing a unique computer algorithm developed at the University of Virginia to measure ABD events and an Multi-channel Intra-luminal Impedance (MII) pH monitoring to measure GER episodes. 2) In a randomized placebo-controlled trial, the investigators will study whether erythromycin decreases GER and GER-associated apnea, bradycardia and/or hypoxia in premature infants.
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia
- Being tested
- Erythromycin, Multi-channel intra-luminal impedance (MII) pH monitoring, Placebo (D5W)
- Keywords
- neonate, apnea, preterm, reflux, gastroesophageal reflux, impedance, erythromycin, desaturation, bradycardia, hypoxia
- Medical subject headings
- Gastroesophageal Reflux, Apnea, Bradycardia, Premature Birth, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Multi-channel intra-luminal impedance (MII) pH monitoringDevice
Also called Sandhill 6.5 French, product# ZINBS45E
Placebo (D5W)Drug
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Experimental | 50 mg/kg/day divided every 6 hours oral for 7 days Receives: Drug: Erythromycin; Device: Multi-channel intra-luminal impedance (MII) pH monitoring |
| Placebo | Placebo comparator | Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days Receives: Device: Multi-channel intra-luminal impedance (MII) pH monitoring; Drug: Placebo (D5W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
Measured: during day 6 to 7 of study treatment
Secondary outcomes (2)
ABD events per Physiologic Monitoring Database
Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia
Measured: during the entire 7 days of treatment
ABD events recorded by nursing
Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse
Measured: during the entire 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faranek Davalian, MD, University of Virginia
- Investigators
- Fara Davalian, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825473
- Sponsor's protocol ID
- 16220
- Acronym
- SEGAN
- Status last verified
- Apr 2013
- First submitted
- 20 Mar 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Erythromycin in GER-Associated Apnea of the Newborn
- ClinicalTrials.gov ID
- NCT01825473
- Acronym / sponsor ID
- SEGAN / 16220
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia
- Keywords
- neonate, apnea, preterm, reflux, gastroesophageal reflux, impedance, erythromycin, desaturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 5 Apr 2013 (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.
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective randomized controlled trial.
Detailed description
A randomized placebo-controlled trial to determine whether erythromycin, a drug known to enhance gut motility, will improve the incidence of GER and GER-associated apnea, bradycardiac and/or hypoxic events. The investigators have two aims: 1) to examine the relationship between GER and apnea, bradycardia, and/or desaturation (ABD) events by simultaneously employing a unique computer algorithm developed at the University of Virginia to measure ABD events and an Multi-channel Intra-luminal Impedance (MII) pH monitoring to measure GER episodes. 2) In a randomized placebo-controlled trial, the investigators will study whether erythromycin decreases GER and GER-associated apnea, bradycardia and/or hypoxia in premature infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Experimental | Drug: Erythromycin, Device: Multi-channel intra-luminal impedance (MII) pH monitoring50 mg/kg/day divided every 6 hours oral for 7 days |
| Placebo | Placebo comparator | Device: Multi-channel intra-luminal impedance (MII) pH monitoring, Drug: Placebo (D5W)Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days |
Who may qualify
- Ages
- 14 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- major central nervous system, gastrointestinal, or complex cardiac anomalies
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 |
|---|---|---|
| Erythromycin | Drug | Erythromycin |
| Multi-channel intra-luminal impedance (MII) pH monitoringAlso: Sandhill 6.5 French, product# ZINBS45E | Device | Erythromycin, Placebo |
| Placebo (D5W) | Drug | Placebo |
Primary outcome
Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
Time frame: during day 6 to 7 of study treatment
2 secondary outcomes
ABD events per Physiologic Monitoring Database
Time frame: during the entire 7 days of treatment
ABD events recorded by nursing
Time frame: during the entire 7 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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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.
Fara Davalian, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythromycin and Multi-channel intra-luminal impedance (MII) pH monitoring in people with Gastroesophageal Reflux and Apnea, run by University of Virginia at 1 site in United States.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Apr 2013. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fara Davalian, MD (434-924-5428, Fara.Davalian@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance (time frame: during day 6 to 7 of study treatment). 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 5 Apr 2013.