High Versus Low Dose of Caffeine for Apnea of Prematurity

Phase 3

Completed

• Conditions: Apnea; Preterm Infants
• Interventions: Drug: Caffeine citrate

• Registration Number: NCT02103777
• Lead Sponsor: Mansoura University Children Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted: 2014-03-27
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-03
• Last Update Submitted: 2014-04-03
• Study First Posted: 2014-04-04
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose caffeine	Caffeine citrate	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)
Low dose caffeine	Caffeine citrate	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.

Primary Outcome Measures

Name	Time	Method
Successful extubation from mechanical ventilation	72 hours after extubation from mechanical ventilation	Need of re-intubation within 72 hours of extubation from mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	Expected 8 weeks
Hydrocephalus	Expected 8 weeks
Duration of mechanical ventilation and oxygen support	Expected 4 to 6 weeks postnatal age
Necrotising enterocolitis	Expected 6 weeks
Caffeine side effects.	Expected 6 weeks
Chronic lung disease	By 36 weeks corrected gestational age	Need for oxygen by 36 weeks corrected gestational age
Retinopathy of prematurity	Expected 8 weeks
Apnea of prematurity	Expected average of 8 weeks post natal age	Frequency and documented days of apnea
Intraventricular haemorrhage	Expected 2 weeks
Periventricular leukomalacia	Expected 8 weeks
Neonatal mortality	Expected 8 weeks	Death before hospital discharge

Trial Locations

Locations (1)

Mansoura University Children Hospital; 🇪🇬 Mansoura, El Dakahlya, Egypt