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Caffeine for Apnea of Prematurity (CAP)

Primary Purpose

Apnea of Prematurity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Caffeine citrate injection

About this trial

This is an interventional prevention trial for Apnea of Prematurity focused on measuring preterm infants, very low birthweight, apnea of prematurity, methylxanthines, developmental disabilities

Eligibility Criteria

undefined - 10 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: birthweight 500 to 1250 grams postnatal age day 1 to day 10 infant considered a candidate for methylxanthine therapy by clinical staff Exclusion Criteria: dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment unlikely to comply with long-term follow-up prior treatment with a methylxanthine

Outcomes

Primary Outcome Measures

combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months.

Secondary Outcome Measures

bronchopulmonary dysplasia

necrotizing enterocolitis

brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly

retinopathy of prematurity

growth failure

functional status at 5 years and at 11-12 years

Full Information

NCT ID

NCT00182312

First Posted

September 13, 2005

Last Updated

March 20, 2018

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia

1. Study Identification

Unique Protocol Identification Number

NCT00182312

Brief Title

Caffeine for Apnea of Prematurity (CAP)

Official Title

Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 1999 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity. Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apnea of Prematurity

Keywords

preterm infants, very low birthweight, apnea of prematurity, methylxanthines, developmental disabilities

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Caffeine citrate injection

Other Intervention Name(s)

CafCit

Intervention Description

Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection. Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established. Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy.

Primary Outcome Measure Information:

Title

combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months.

Time Frame

corrected age of 18 months

Secondary Outcome Measure Information:

Title

bronchopulmonary dysplasia

Time Frame

discharge home

Title

necrotizing enterocolitis

Time Frame

discharge home

Title

brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly

Time Frame

discharge home

Title

retinopathy of prematurity

Time Frame

discharge home

Title

growth failure

Time Frame

corrected age of 18 months

Title

functional status at 5 years and at 11-12 years

Time Frame

corrected age of 5 years and chronological age of 11-12 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

10 Days

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: