High Versus Low Dose of Caffeine for Apnea of Prematurity

NCT ID: NCT02103777

Last Updated: 2014-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

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.

Conditions

Apnea; Preterm Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Caffeine citrate

Intervention Type: DRUG

Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

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.

Group Type: ACTIVE_COMPARATOR

Caffeine citrate

Intervention Type: DRUG

Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

Interventions

Caffeine citrate

Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Children Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nehad Nasef

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sameh m abbas, master

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Children Hospital

nehad a nasef, MD

Role: STUDY_DIRECTOR

Mansoura University Children Hospital

Locations

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, Egypt

Countries

Egypt

Other Identifiers

NICU MUCH 2013

Identifier Type: -

Identifier Source: org_study_id