Caffeine for Apnea of Prematurity (CAP)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00182312
Study type	Interventional
Source	McMaster University
Contact
Status	Completed
Phase	Phase 3
Start date	October 1999
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03670732` - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure	N/A
Terminated	`NCT02524249` - Early Versus Late Caffeine for ELBW Newborns	N/A
Completed	`NCT03292562` - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation	N/A
Recruiting	`NCT05298748` - The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants	N/A
Recruiting	`NCT05968586` - Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants	N/A
Active, not recruiting	`NCT02641249` - Non-invasive Intervention for Apnea of Prematurity	N/A
Terminated	`NCT01911182` - Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea	Phase 2/Phase 3
Recruiting	`NCT03651648` - Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.	N/A
Recruiting	`NCT03298347` - Caffeine for Preterm Infants With Apnea of Prematurity(AOP)	N/A
Completed	`NCT01020357` - Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study	Phase 3
Completed	`NCT00809055` - MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine	Phase 4
Completed	`NCT03298035` - A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants	N/A
Completed	`NCT03695900` - Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants	N/A
Completed	`NCT04327466` - Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants	N/A
Not yet recruiting	`NCT06374147` - "Prapela® SVS Incubator Pad for Apnea of Prematurity	N/A
Completed	`NCT04868565` - Target Weaning Oxygen to Determine Cafffeine Duration for AOP	Phase 4
Terminated	`NCT00482040` - Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity	N/A
Not yet recruiting	`NCT06292299` - The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Completed	`NCT05393817` - Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes
Recruiting	`NCT04430790` - Doxapram Therapy in Preterm Infants (DOXA Trial)	Phase 3