Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Apnea Clinical Trial

Official title:

Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677584
• Other study ID #: R / 15.06.75
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 2018

Study information

• Verified date: March 2021
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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 .

Related Conditions & MeSH terms

• Apnea

Intervention

Drug:
• Prophylactic 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) .
• Therapeutic 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).

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansoura	El Dakahlya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Erratum in: J Pediatr. 2014 May;164(5):1244. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Respiratory Support		60 days from NICU admission
Secondary	Days of apnea free		60 days from NICU admission
Secondary	length of hospital stay		60 days from NICU admission
Secondary	Head ultrasound results	Any grade of intraventricular hemorrhage (IVH); periventricular leukomalacia (PVL)	14 days from NICU admission
Secondary	Necrotizing Enterocolitis	Any stage, according to modified Bell classification	30 days from NICU admission
Secondary	Retinopathy of prematurity	Any stage, according to International classification of retinopathy of prematurity (ICROP)	60 days from NICU admission