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The optimum caffeine dose for apnea of prematurity has not been well investigated so the objective of the study is to compare high versus low dose of caffeine citrate to facilitate successful extubation in mechanically ventilated preterm infants.
A randomized, double blind, clinical trial which will be conducted in Neonatal Intensive Care Unit, Mansoura University Children Hospital, Egypt on preterm infants born less than 32 weeks gestation mechanically ventilated within the first 10 days of life to study the optimum caffeine dose for apnea of prematurity and compare High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine citrate started within the first 10 days of life and its effect on need of re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome and frequency and duration of apnea, duration of mechanical ventilation and oxygen support, length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of prematurity, and caffeine side effects as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose caffeine | Active Comparator | High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) |
|
| Low dose caffeine | Active Comparator | Low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine citrate | Drug | Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful extubation from mechanical ventilation | Need of re-intubation within 72 hours of extubation from mechanical ventilation | 72 hours after extubation from mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea of prematurity | Frequency and documented days of apnea | Expected average of 8 weeks post natal age |
| Duration of mechanical ventilation and oxygen support | Expected 4 to 6 weeks postnatal age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sameh m abbas, master | Mansoura University Children Hospital | Principal Investigator |
| nehad a nasef, MD | Mansoura University Children Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Children Hospital | Al Mansurah | El Dakahlya | 35111 | Egypt |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C026189 | caffeine citrate |
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| length of hospital stay | Expected 8 weeks |
| Neonatal mortality | Death before hospital discharge | Expected 8 weeks |
| Chronic lung disease | Need for oxygen by 36 weeks corrected gestational age | By 36 weeks corrected gestational age |
| Necrotising enterocolitis | Expected 6 weeks |
| Intraventricular haemorrhage | Expected 2 weeks |
| Periventricular leukomalacia | Expected 8 weeks |
| Hydrocephalus | Expected 8 weeks |
| Retinopathy of prematurity | Expected 8 weeks |
| Caffeine side effects. | Expected 6 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |