Clinical trial NCT02103777: High Versus Low Dose of Caffeine for Apnea of Prematurity
Official title: High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Apnea
Preterm Infants
Keywords: high dose of caffeine
low dose of caffeine
prevention
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful extubation from mechanical ventilation
timeFrame: 72 hours after extubation from mechanical ventilation
Secondary outcomes:
measure: Apnea of prematurity
timeFrame: Expected average of 8 weeks post natal age
measure: Duration of mechanical ventilation and oxygen support
timeFrame: Expected 4 to 6 weeks postnatal age
measure: length of hospital stay
timeFrame: Expected 8 weeks
measure: Neonatal mortality
timeFrame: Expected 8 weeks
measure: Chronic lung disease
timeFrame: By 36 weeks corrected gestational age
measure: Necrotising enterocolitis
timeFrame: Expected 6 weeks
measure: Intraventricular haemorrhage
timeFrame: Expected 2 weeks
measure: Periventricular leukomalacia
timeFrame: Expected 8 weeks
measure: Hydrocephalus
timeFrame: Expected 8 weeks
measure: Retinopathy of prematurity
timeFrame: Expected 8 weeks
measure: Caffeine side effects.
timeFrame: Expected 6 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
state: El Dakahlya
Study officials:
affiliation: Mansoura University Children Hospital
name: sameh m abbas, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Children Hospital
name: nehad a nasef, MD
role: STUDY_DIRECTOR
References: