Apnea, Preterm Infants
Conditions
Keywords
high dose of caffeine, low dose of caffeine, 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.
Interventions
DRUGCaffeine citrate
Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2
Sponsors
Mansoura University Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful extubation from mechanical ventilation | 72 hours after extubation from mechanical ventilation | Need of re-intubation within 72 hours of extubation from mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation and oxygen support | Expected 4 to 6 weeks postnatal age | — |
| length of hospital stay | Expected 8 weeks | — |
| Neonatal mortality | Expected 8 weeks | Death before hospital discharge |
| Chronic lung disease | By 36 weeks corrected gestational age | Need for oxygen by 36 weeks corrected gestational age |
| Necrotising enterocolitis | Expected 6 weeks | — |
| Apnea of prematurity | Expected average of 8 weeks post natal age | Frequency and documented days of apnea |
| Periventricular leukomalacia | Expected 8 weeks | — |
| Hydrocephalus | Expected 8 weeks | — |
| Retinopathy of prematurity | Expected 8 weeks | — |
| Caffeine side effects. | Expected 6 weeks | — |
| Intraventricular haemorrhage | Expected 2 weeks | — |
Countries
Egypt
Outcome results
None listed