High Versus Low Dose of Caffeine for Apnea of Prematurity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial

Conditions
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Apnea, Preterm Infants

Intervention / Treatment
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* Drug: Caffeine citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newborn infant less than 32 weeks gestation with the diagnosis of apnea Exclusion Criteria: newborn infants with gestational age more than 32 weeks. newborn infant with congenital malformations or chromosomal anomalies.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose caffeine<br>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) | Drug: Caffeine citrate<br>* Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2<br>|
| Active Comparator: Low dose caffeine<br>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. | Drug: Caffeine citrate<br>* Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high dose of caffeine, low dose of caffeine, prevention