High Versus Low Dose of Caffeine for Apnea of Prematurity

Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103777
• Other study ID #: NICU MUCH 2013
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2014
• Last updated: April 3, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Preterm Infants

Intervention

Drug:
• Caffeine citrate
Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful extubation from mechanical ventilation	Need of re-intubation within 72 hours of extubation from mechanical ventilation	72 hours after extubation from mechanical ventilation	No
Secondary	Apnea of prematurity	Frequency and documented days of apnea	Expected average of 8 weeks post natal age	No
Secondary	Duration of mechanical ventilation and oxygen support		Expected 4 to 6 weeks postnatal age	No
Secondary	length of hospital stay		Expected 8 weeks	No
Secondary	Neonatal mortality	Death before hospital discharge	Expected 8 weeks	No
Secondary	Chronic lung disease	Need for oxygen by 36 weeks corrected gestational age	By 36 weeks corrected gestational age	No
Secondary	Necrotising enterocolitis		Expected 6 weeks	No
Secondary	Intraventricular haemorrhage		Expected 2 weeks	No
Secondary	Periventricular leukomalacia		Expected 8 weeks	No
Secondary	Hydrocephalus		Expected 8 weeks	No
Secondary	Retinopathy of prematurity		Expected 8 weeks	No
Secondary	Caffeine side effects.		Expected 6 weeks	Yes