Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Study Overview
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Brief Summary
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Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine

Detailed Description
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It will be a randomized control trial, patients will be randomly assigned to receive caffeine in a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) and a maintenance dose of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base) either as a prophylaxis group (1) or therapeutic group (2). Prophylactic caffeine (group 1) will be defined as caffeine prescribed for preterm infants within the first 72 hours of life prior to manifest apnea , therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . Preparation and administration of caffeine will be performed by a Neonatal intensive care unit (NICU) nurse. Statistical Evaluation: Statistical analyses will be performed with the Statistical Package for Social Sciences-SPSS version 16 software (SPSS Inc, Chicago, Illinois). For categorical variables, the X2 test will be used. For group comparisons, the Student T test will be used in normal distribution and the Mann-Whitney U test will be used in case of abnormal distribution. For repeating measurements, variance analyses and Friedman variance analyses will be used. For descriptive statistics, percent, minimum-maximum-median, mean, and standard deviation will be used in accordance with the type and distribution of the variable. A P value <.05 was considered statistically significant. Informed consent will be obtained from parents, and the study will be approved by the local ethical committee.

Official Title
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Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Conditions
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Apnea

Intervention / Treatment
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* Drug: Prophylactic caffeine citrate
* Drug: Therapeutic caffeine citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants eligible for this study will be newborn infants ≤ 32 weeks with or without a diagnosis of apnea . Exclusion Criteria: Newborn infants with gestational age > 32 weeks. Newborn infants with congenital malformations and chromosomal anomalies. Newborn infants with apnea of other causes .

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 12 Weeks

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prophylactic caffeine citrate<br>Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) . | Drug: Prophylactic caffeine citrate<br>* Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .<br>|
| Active Comparator: Therapeutic caffeine citrate<br>Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base). | Drug: Therapeutic caffeine citrate<br>* Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Respiratory Support |  | 60 days from NICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of apnea free |  | 60 days from NICU admission | 
| length of hospital stay |  | 60 days from NICU admission | 
| Head ultrasound results | Any grade of intraventricular hemorrhage (IVH); periventricular leukomalacia (PVL) | 14 days from NICU admission | 
| Necrotizing Enterocolitis | Any stage, according to modified Bell classification | 30 days from NICU admission | 
| Retinopathy of prematurity | Any stage, according to International classification of retinopathy of prematurity (ICROP) | 60 days from NICU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnea, caffeine, preterm infant