Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Mansoura University Children Hospital180 enrolled

Overview

Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Apnea

Interventions

Prophylactic caffeine citrateDRUG

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) .

Therapeutic caffeine citrateDRUG

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).

Eligibility

Sex: ALLMin age: 1 HourMax age: 12 Weeks

Medical Language ↔ Plain English

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 .

Locations (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, Egypt

Outcomes

Primary Outcomes

Duration of Respiratory Support

Time frame: 60 days from NICU admission

Secondary Outcomes

Days of apnea free

Time frame: 60 days from NICU admission

length of hospital stay

Time frame: 60 days from NICU admission

Head ultrasound results

Any grade of intraventricular hemorrhage (IVH); periventricular leukomalacia (PVL)

Time frame: 14 days from NICU admission

Necrotizing Enterocolitis

Any stage, according to modified Bell classification

Time frame: 30 days from NICU admission

Retinopathy of prematurity

Any stage, according to International classification of retinopathy of prematurity (ICROP)

Time frame: 60 days from NICU admission

Data from ClinicalTrials.gov

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