Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity
- Conditions
- Apnea
- Interventions
- Registration Number
- NCT02677584
- Lead Sponsor
- Mansoura University Children Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Infants eligible for this study will be newborn infants ≤ 32 weeks with or without a diagnosis of apnea .
- Newborn infants with gestational age > 32 weeks.
- Newborn infants with congenital malformations and chromosomal anomalies.
- Newborn infants with apnea of other causes .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prophylactic caffeine citrate Prophylactic caffeine citrate 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) . Therapeutic caffeine citrate Therapeutic caffeine citrate 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).
- Primary Outcome Measures
Name Time Method Duration of Respiratory Support 60 days from NICU admission
- Secondary Outcome Measures
Name Time Method Days of apnea free 60 days from NICU admission length of hospital stay 60 days from NICU admission Head ultrasound results 14 days from NICU admission Any grade of intraventricular hemorrhage (IVH); periventricular leukomalacia (PVL)
Necrotizing Enterocolitis 30 days from NICU admission Any stage, according to modified Bell classification
Retinopathy of prematurity 60 days from NICU admission Any stage, according to International classification of retinopathy of prematurity (ICROP)
Trial Locations
- Locations (1)
Mansoura University Children Hospital
🇪🇬Mansoura, El Dakahlya, Egypt