High Versus Low Dose of Caffeine for Apnea of Prematurity

Mansoura University Children Hospital

Status and phase: Completed; Phase 3

Conditions: Preterm Infants; Apnea

Treatments: Drug: Caffeine citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02103777

NICU MUCH 2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 1 to 10 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

High dose caffeine

Active Comparator group

Description:

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)

Treatment:

Drug: Caffeine citrate

Low dose caffeine

Active Comparator group

Description:

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.

Treatment:

Drug: Caffeine citrate