Apnea
Conditions
Keywords
caffeine, apnea, preterm infant
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.
Interventions
DRUGProphylactic 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) .
DRUGTherapeutic 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).
Sponsors
Mansoura University Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 12 Weeks
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Respiratory Support | 60 days from NICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed