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| ID | Type | Description | Link |
|---|---|---|---|
| Nishtar Hospital Multan | Other Identifier | Nishtar Hospital Multan |
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High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success rate, lower extubation failure rate and shorter duration of oxygen therapy
Apnea of prematurity (AOP) is a common condition in preterm infants due to immature respiratory control, affecting up to 80% of those under 1000 grams. It can lead to serious complications, including respiratory distress, pulmonary hemorrhage, and developmental delays. Caffeine citrate, a methylxanthine, is widely used for AOP treatment due to its longer half-life and better absorption compared to theophylline. However, the optimal dosage remains uncertain, with varying practices globally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Group | Experimental | High dose group will be administered a loading dose of oral caffeine citrate at 40 mg/kg/day followed by a maintenance dose of 20 mg/kg/day for 7 days |
|
| Low-Dose Group | Experimental | Low-dose group will receive a loading dose of 20 mg/kg/day and a maintenance dose of 10 mg/kg/day for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose | Drug | Caffeine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced Respiratory Stimulation, Effect of Caffeine Citrate on the stimulation of respiratory system of premature individuals | High dose vs low dose caffeine citrate effect in apnea of prematurity. The concentration of caffeine citrate as 40mg high dose and 20mg low dose will be considered. The measurement tool will be percentage of patients recovering from this high vs low concentration. The effect of caffeine citrate doses on respiratory stimulation of premature babies will be studied. High doses are expected to improve respiratory distress associated with prematurity. Patients will be clinically assessed after the given doses of caffeine citrate and any improvement, if present, will be noted. | 2-3 days after starting the intervention |
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Inclusion Criteria:
• Patients with a gestational age of ≥32 and <37 weeks at birth on LMP.
Exclusion Criteria:
• Patients diagnosed with Hydrops fetalis (evaluated through medical record).
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| Name | Affiliation | Role |
|---|---|---|
| Fatima Zahra, FCPS | Nishtar Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar Medical Hospital, Multan | Multan | Punjab Province | 60000 | Pakistan |
Patient privacy will be our priority. Consent will be taken from patient for participation in study.
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| ID | Term |
|---|---|
| D001049 | Apnea |
| D047928 | Premature Birth |
| 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 |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Low Dose | Drug | Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates. |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |