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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2
Mansoura University Children Hospital
Al Mansurah, El Dakahlya, Egypt
Successful extubation from mechanical ventilation
Need of re-intubation within 72 hours of extubation from mechanical ventilation
Time frame: 72 hours after extubation from mechanical ventilation
Apnea of prematurity
Frequency and documented days of apnea
Time frame: Expected average of 8 weeks post natal age
Duration of mechanical ventilation and oxygen support
Time frame: Expected 4 to 6 weeks postnatal age
length of hospital stay
Time frame: Expected 8 weeks
Neonatal mortality
Death before hospital discharge
Time frame: Expected 8 weeks
Chronic lung disease
Need for oxygen by 36 weeks corrected gestational age
Time frame: By 36 weeks corrected gestational age
Necrotising enterocolitis
Time frame: Expected 6 weeks
Intraventricular haemorrhage
Time frame: Expected 2 weeks
Periventricular leukomalacia
Time frame: Expected 8 weeks
Hydrocephalus
Time frame: Expected 8 weeks
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Retinopathy of prematurity
Time frame: Expected 8 weeks
Caffeine side effects.
Time frame: Expected 6 weeks