High Versus Low Dose of Caffeine for Apnea of Prematurity

High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Apnea; Preterm Infants
• Intervention / Treatment: Drug: Caffeine citrate

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • El Dakahlya
    • Mansoura, El Dakahlya, Egypt, 35111
      • Mansoura University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High dose caffeine; 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)	Drug: Caffeine citrate; Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2
Active Comparator: Low dose caffeine; 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.	Drug: Caffeine citrate; Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful extubation from mechanical ventilation	Need of re-intubation within 72 hours of extubation from mechanical ventilation	72 hours after extubation from mechanical ventilation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital
• Investigators: Principal Investigator: sameh m abbas, master, Mansoura University Children Hospital; Study Director: nehad a nasef, MD, Mansoura University Children Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2014
• Last Update Submitted That Met QC Criteria: April 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: prevention; high dose of caffeine; low dose of caffeine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine; Caffeine citrate
• Other Study ID Numbers: NICU MUCH 2013