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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Group | Late preterm infants without any pathology. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oxymeter measurements | Other | Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age |
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| Measure | Description | Time Frame |
|---|---|---|
| Pattern of Oxygen saturation | Measurements at hospital and weekly after discharge | Up to 46 weeks postconceptional age |
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Inclusion Criteria of infants admitted to NICU:
Exclusion Criteria of all infants:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Carlos A Fajardo, Md | University of Calgary | Principal Investigator |
| Veronica Samedi, Md | Alberta Health services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Logheed Center | Calgary | Alberta | T1Y 6J4 | Canada |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |