Clinical trial NCT02677584: Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity
Official title: Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea
Keywords: caffeine
apnea
preterm infant
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Duration of Respiratory Support
timeFrame: 60 days from NICU admission
Secondary outcomes:
measure: Days of apnea free
timeFrame: 60 days from NICU admission
measure: length of hospital stay
timeFrame: 60 days from NICU admission
measure: Head ultrasound results
timeFrame: 14 days from NICU admission
measure: Necrotizing Enterocolitis
timeFrame: 30 days from NICU admission
measure: Retinopathy of prematurity
timeFrame: 60 days from NICU admission
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
state: El Dakahlya
Study officials:
References:
citation: Dobson NR, Patel RM, Smith PB, Kuehn DR, Clark J, Vyas-Read S, Herring A, Laughon MM, Carlton D, Hunt CE. Trends in caffeine use and association between clinical outcomes and timing of therapy in very low birth weight infants. J Pediatr. 2014 May;164(5):992-998.e3. doi: 10.1016/j.jpeds.2013.12.025. Epub 2014 Jan 23.
citation: Katheria AC, Sauberan JB, Akotia D, Rich W, Durham J, Finer NN. A Pilot Randomized Controlled Trial of Early versus Routine Caffeine in Extremely Premature Infants. Am J Perinatol. 2015 Jul;32(9):879-86. doi: 10.1055/s-0034-1543981. Epub 2015 Jan 21.