PrematurityOCPDPSNCT02386046
Oxygen Saturation and Caffeine Post-Discharge
An observational study of Prematurity, run by University of Calgary at 1 site in Canada.
Trial summary
This study aims to determine normative values of oxygen saturation in late preterm infants, and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and those not requiring it. Read more about this study
- Who is it for?
- Ages 26 to 46 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Pulse oxymeter measurements
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to 31 Oct 2017
- 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 26 to 46 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn infants admitted at two NICU centers in Calgary born prematurely between 26 weeks and 34 weeks of gestational age. Newborn infants admitted directly to the normal nursery in those two centers born less than 38 weeks.
Who may be able to join
- Gestational age at birth of < or = 35 weeks
- Families of infants that live in Calgary
- Infants discharged home from PLC or South Health Campus (SHC)
- Decision of treating team to start caffeine
- No episodes of clinically significant apnea for a period of 3 to 5 days prior to discharge
- Infant has access to reliable post-discharge follow up
Who cannot join
- Active serious medical conditions other than apnea (Congenital Heart Disease (CHD), Chronic Lung Disease (CLD), symptomatic anemia).
- Congenital disorders like Trisomies, genetic syndromes, midline defects, metabolic disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of Caffeine Post Discharge Normalize the Respiratory Patterns in Infants Born Earlier Than 35 Weeks? A Cohort Study
This study aims to determine normative values of oxygen saturation in late preterm infants, and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and those not requiring it.
Read the detailed description
Apnea of prematurity is a common morbidity among premature infants. Recent studies suggest an association between apnea and neurodevelopmental impairment. Our objectives are to determine normative values of oxygen saturation in late preterm infants -reference group. In infants born 28-35 weeks requiring caffeine- study group and infants born 28-35 weeks not requiring caffeine-control group we will be evaluating the frequency of hypoxic events. Recruitment time: February 2015 until December 2016.
After consent a pulse oxymeter will be placed on the infant's right wrist. For those infants that will receive caffeine prior to discharge, this medication will be instituted after 12 hours of the initiation of the study and continue for the remaining of the hospitalization. For all other infants, the pulse oxymeter will be done continuously until discharge. After discharge, the recording will be done at home once a week until 46 weeks corrected age in the three groups.
All the data will be reviewed by a blind observer to the groups from which that data comes. The data will be analyzed by a statistician.
Normative values will be developed on the reference group until 46 weeks post conceptional age.
Any medical problems encounter by the patients while on the study or in the following 6 months will be recorded to establish the safety of caffeine use at home and its discontinuation at 44 weeks post conceptional age.
- Conditions
- Prematurity
- Being tested
- Pulse oxymeter measurements
- Keywords
- Caffeine use, Normative data
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oxymeter measurementsOther
Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age
| Study group | Role | What they receive |
|---|---|---|
| Reference Group | Late preterm infants without any pathology. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age. Receives: Other: Pulse oxymeter measurements | |
| Study Group | Infants born 26-35 weeks requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital before and after caffeine instituted, and weekly thereafter until 46 weeks postconceptional age. Receives: Other: Pulse oxymeter measurements | |
| Control Group | Infants born 26-35 weeks not requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age. Receives: Other: Pulse oxymeter measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of Oxygen saturation
Measurements at hospital and weekly after discharge
Measured: Up to 46 weeks postconceptional age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fajardo, University of Calgary
- Investigators
- Carlos A Fajardo, Md, Principal investigator, University of CalgaryVeronica Samedi, Md, Study director, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386046
- Sponsor's protocol ID
- REB14-0175
- Acronym
- OCPDPS
- Status last verified
- May 2017
- First submitted
- 5 Mar 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Caffeine Post Discharge Normalize the Respiratory Patterns in Infants Born Earlier Than 35 Weeks? A Cohort Study
- ClinicalTrials.gov ID
- NCT02386046
- Acronym / sponsor ID
- OCPDPS / REB14-0175
- Conditions
- Prematurity
- Keywords
- Caffeine use, Normative data
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 11 Mar 2015 (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.
This study aims to determine normative values of oxygen saturation in late preterm infants, and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and those not requiring it.
Detailed description
Apnea of prematurity is a common morbidity among premature infants. Recent studies suggest an association between apnea and neurodevelopmental impairment. Our objectives are to determine normative values of oxygen saturation in late preterm infants -reference group. In infants born 28-35 weeks requiring caffeine- study group and infants born 28-35 weeks not requiring caffeine-control group we will be evaluating the frequency of hypoxic events. Recruitment time: February 2015 until December 2016.
After consent a pulse oxymeter will be placed on the infant's right wrist. For those infants that will receive caffeine prior to discharge, this medication will be instituted after 12 hours of the initiation of the study and continue for the remaining of the hospitalization. For all other infants, the pulse oxymeter will be done continuously until discharge. After discharge, the recording will be done at home once a week until 46 weeks corrected age in the three groups.
All the data will be reviewed by a blind observer to the groups from which that data comes. The data will be analyzed by a statistician.
Normative values will be developed on the reference group until 46 weeks post conceptional age.
Any medical problems encounter by the patients while on the study or in the following 6 months will be recorded to establish the safety of caffeine use at home and its discontinuation at 44 weeks post conceptional age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Group | – | Other: Pulse oxymeter measurementsLate preterm infants without any pathology. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age. |
| Study Group | – | Other: Pulse oxymeter measurementsInfants born 26-35 weeks requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital before and after caffeine instituted, and weekly thereafter until 46 weeks postconceptional age. |
| Control Group | – | Other: Pulse oxymeter measurementsInfants born 26-35 weeks not requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age. |
Who may qualify
- Ages
- 26 to 46 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn infants admitted at two NICU centers in Calgary born prematurely between 26 weeks and 34 weeks of gestational age. Newborn infants admitted directly to the normal nursery in those two centers born less than 38 weeks.
Key inclusion criteria (6 listed)
- Gestational age at birth of < or = 35 weeks
- Families of infants that live in Calgary
- Infants discharged home from PLC or South Health Campus (SHC)
- Decision of treating team to start caffeine
- No episodes of clinically significant apnea for a period of 3 to 5 days prior to discharge
Key exclusion criteria (2 listed)
- Active serious medical conditions other than apnea (Congenital Heart Disease (CHD), Chronic Lung Disease (CLD), symptomatic anemia).
- Congenital disorders like Trisomies, genetic syndromes, midline defects, metabolic disorders.
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 |
|---|---|---|
| Pulse oxymeter measurementsPulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age | Other | Control Group, Reference Group, Study Group |
Primary outcome
Pattern of Oxygen saturation
Time frame: Up to 46 weeks postconceptional age
Measurements at hospital and weekly after discharge
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Prematurity
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Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
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Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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.
Carlos A Fajardo, Md principal investigator
University of Calgary
Veronica Samedi, Md study director
Alberta Health services
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 Prematurity, run by University of Calgary 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 17 Apr 2019. 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 was stopped early. Results are not available in the source record.
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?
Pattern of Oxygen saturation (time frame: Up to 46 weeks postconceptional age). 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 17 Apr 2019.